cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin to Improve Results in Epicanthoplasty

Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50% Asia population, giving the illusion of a shorter palpebral fissure length and a wider intercanthal distance. Currently, various epicanthoplasty techniques have been well described to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease, recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional denervation of striated muscle for 2 to 6 months after injection. Recently, experimental study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts derived from hypertrophic scars and influenced the expression of transforming growth factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth, and reduce collagen production. The main aim of this trail is to evaluate the efficiency of BTX-A injection on improving hypertrophic scaring after epicanthoplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate to severe congenital epicanthus.
* patients accept Park Z epicanthoplasty.
* Written informed consent given

Exclusion Criteria:

* epicanthus caused by trauma, surgical injury.
* patients with both epicanthus and blepharopotosis.
* patients with blepharophimosis-ptosis-epicanthus inversus syndrome, or only inversus epicanthus
* patients underwent Botulinum Toxin Type A periocular injection within 6 months
* patients ever have been allergic to Botulinum Toxin Type A or any components of Botulinum Toxin Type A
Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother.

In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured.

Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Eligibility Criteria:
Inclusion Criteria:

* For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.
* For children follow up: children born to positive mothers and matched controls after written consent

Exclusion Criteria:

* none
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery

Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)

Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)

Eligibility Criteria:
Inclusion Criteria:

* Age from 50 to 60 years
* Patients undergoing elective upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
* Non-smoker patients

Exclusion Criteria:

* Patients developing cancer
* Patients with rib fractures
* Inability to comprehend and follow instructions.
* Pre-existing obstructive sleep apnea
* Current hospital patient for a separate episode of care.
* Patients requiring esophageal surgery or organ transplant.
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing

Claw toes deformity result in spasticity often seem in patients with central nerve disease. It also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. There are few relative reports about the Botulinum toxin type A (BTX-A) injection on claw toe. The investigators' study has two main purposes:

1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes.
2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.

The investigators will enroll 50 hemiplegic stroke patients met the inclusion criteria(onset more than 6 month, lower extremity Brunnstrome stage more than stage IV, walking without assistance devices and pain during walking due to claw toe. The investigators will focus and inject BTX-A with ultrasonographyic guidance on flexor digitorum longus and brevis(both 50 unit). If patients combine ankle plantar flexors spasticity, the investigators will inject another 50 unit on both the medial and lateral head of gastrocnemius . Every patients will receive regular stretching exercise in hospital and do self stretching exercise at home for 3 months after injection. Patients will be evaluated at 2 weeks, 4 weeks and 12 weeks, 24 weeks and 1 year after injection. Outcome measure include severity of spasticity and pain, sensory and motor function, range of motion, functional assessment of lower extremity and analyze pressure under foot.

Eligibility Criteria:
Inclusion Criteria:

* Patient with spasticity toe clawing(metatarsophalange jointextension, proximal and distal phalange joint flexion)
* MAS scale of metatarsophalange joint and interphalangeal joint more than 2
* Pain during walking, abnormal gait patterns and can't wear shoess due to claw toe
* Haven't received botox or phenol or alcohol injections before

Exclusion Criteria:

* Lower extremities joint contrature, bone deformity
* Had received botox injections or phenol injections or before due to lower extremities spasticity
* Combine other neuromuscular system disease
* Severe cognition disorder or aphasia after stroke
* Significant atrophy of flexor digitorum longus and brevis
* Allergy to botox
* Infection on injection site
* Have systemic infection
* Now accept aminioglycoside or other medicine will affect neuromusclar transition
tDCS in MCS: Repeated Stimulations

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-r total score at the end of the anodal session and that this improvement persists for a week.

Eligibility Criteria:
Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 3 months after the acute brain injury
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
Cardiac Magnetic Resonance Features and Outcomes of Patients With Non-Compaction Cardiomyopathy - a Retrospective Follow-up From Pakistan

Objective: To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.

Left Ventricle Non-Compaction Cardiomyopathy (LVNCC) is a type of myocardial disease characterized by prominent myocardial trabeculae and recesses resulting in two distinct layers of myocardium: compacted layer and the non-compacted layer. It arises due to the failure of left ventricle (LV) maturation and compaction during intra-uterine life (1). As per the position statement from the European Society of Cardiology, LVNCC has been labelled as 'unclassified' type of cardiomyopathy. Clinical course can be complicated by heart failure, thromboembolism, or arrhythmia.

Phenotypic presentation of LVNC can range from extremely thickened layer of non-compacted myocardium to mere presence of prominent trabeculae and recesses albeit a compacted myocardium. Transthoracic echocardiography is the first tool to diagnose LVNC. However, Cardiac Magnetic Resonance (CMR) imaging has emerged as a strong tool to differentiate between LVNCC from mere hyper-trabeculated LV myocardium when echocardiogram is inconclusive (Figure 1 and Video 1). Various criteria have evolved to diagnose LVNC by CMR. Peterson et al defined the end-diastole non-compacted to compacted myocardium ratio of \>2.3 to have good sensitivity, specificity, and negative predictive value for differentiating pathological non-compaction from hyper-trabeculation.

With an increase in the use of diagnostic cardiovascular imaging modalities in South-Asian (SA) belt, LVNC is being increasingly diagnosed. The exact prevalence of LVNC in SA is not known and phenotypic CMR characteristics, clinical features, and outcomes of LVNC remain unknown for SA population. This brought us to the need of analysing CMR data of LVNC at our centre.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years, referred for CMR for further evaluation of cardiomyopathy.

Exclusion Criteria:

* patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study.
Assessment of Optimal Egg Intake in a Healthy Population

Recently, the United States Department of Agriculture (USDA) has recommended removal of the 300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a connection between cholesterol intake and increased risk for cardiovascular disease (CVD). Previous work has shown that daily intake of eggs actually favorably alters many parameters associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a threshold of daily egg intake at which the risk for CVD is not negatively impacted in a young, healthy population.

The purpose of this study is to establish a threshold of egg intake at which CVD risk is not negatively altered in young, healthy individuals. Participants (age 18-30, healthy lipid profile) will undergo a 2-week washout period followed by daily intake of 1, 2, and 3 eggs per day for 4 weeks each. Blood samples will be collected at baseline and following each 4-week dietary period. Samples will be analyzed to determine the impact of daily intake of increasing numbers of eggs on blood lipids, TMAO, biomarkers of oxidative stress and inflammation, and expression of cholesterol-related genes.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-29.9 kg/m2
* Proficient in English
* Cholesterol ≤ 240 mg/dL
* Willing to consume 1, 2, and 3 eggs per day for 4 weeks each

Exclusion Criteria:

* Diabetes mellitus, cardiovascular disease, history of stroke, renal disease, liver disease, cancer, or eating disorder
* Taking glucose-lowering supplements or medications
* Taking triglyceride-lowering medications, bile acid sequestrants, or high-dose chromium or cinnamon supplements
* Plasma glucose \< 126 mg/dL, triglycerides \> 500 mg/dL, or blood pressure \> 140/90 mmHg (average of 3 readings)
* Allergy to eggs
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Eligibility Criteria:
Inclusion Criteria:

* Severe COPD
* At least one COPd exacerbation in previous year

Exclusion Criteria:

* Asthma, allergic rhinitis or other atopic disease
* Unstable concurrent disease:
* Evidence of heart failure
Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 75 years old
2. ECOG: 0～2
3. Life expectancy longer than 3 months
4. Histological proven unresectable recurrent or metastatic HR positive/HER2 negative breast cancer
5. Primary endocrine resistance is defined as: a relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of first-line ET for MBC, while on ET
6. At least one measurable disease according to RECIST 1.1(except for bone metastasis only)
7. LVEF ≥ 55%
8. No radiation therapy within 4 weeks prior to enrollment
9. Normal function of major organs: Hb ≥ 90 g/L (no blood transfusion within 14 days) ;ANC ≥1.5×109 /L；PLT ≥75×109 /L；TBIL≤1. 5×ULN; ALT、 AST≤ 3×ULN（ALT、 AST≤ 5×ULN with hepatic metastases）; serum Cr ≤ 1×ULN
10. Be willing to participate in the study, sign informed consent and cooperate with the follow-up

Exclusion Criteria:

1. Previous accumulated or equivalent dose of doxorubicin ≥300mg/m2
2. Intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse)
3. Patients with symptomatic central nervous system metastases. Except for patients with stable and asymptomatic brain metastases for at least 8 weeks and no need for glucocorticoids or mannitol treatment before the trial and at least one measurable lesion outside the brain. Radiotherapy for brain metastases should be completed at least 4 weeks before the registration
4. Pregnant or lactating women and gestational age women who are unable to use effective contraception
5. Treatment with investigational products within 4 weeks before the study
6. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
7. Severe or uncontrolled infection
8. Psychiatric drugs abuse and unable to withdrawal or mental disorders
9. Other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.

The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-60 years
* BMI \> 20kg/m2 and \<35kg/m2

Exclusion Criteria:

* Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study
* Use of GH or growth hormone stimulating peptides within six months of starting the study
* Change in lipid lowering or antihypertensive regimen within 3 months of screening
* Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, Hgb \< 12.0 g/dL, creatinine \> 1.4 mg/dL
* Carpal tunnel syndrome
* Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
* For men, history of prostate cancer or evidence of prostate malignancy by PSA \> 5 ng/mL
* Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
* Weight \< 110 lbs.
Topical Thymoquinone in Psoriasis Vulgaris

A previous trial found that N. sativa oil was more effective as an antipsoriatic agent, particularly when taken as both a cream and a pill. This confirmed that N. sativa possesses antipsoriatic properties and can alleviate psoriasis symptoms

Psoriasis is a systemic chronic relapsing immune-mediated disease which often requires a long-term therapy. Psoriasis occurs in around 2-3% of the total global population. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3%.

Besides, it could have profound implications on the patients' psychological state and quality of life.

It is presented by erythematous, scaly plaques over the preferred sites. The pathogenesis of this highly complex disease is still far from being fully understood. Keratinocytes' hyperproliferation and immune system dysfunctions are well recognized contributors, with numerous treatments targeting these unique immunologic dysfunctions.

Topical therapy for psoriasis is a current trending subject as it implies good compliance for the patient, few adverse systemic reactions and a targeted effect. Numerous substances are now being tested, from natural to synthetic compounds and already known substances in improved formulas such as vesicular systems.

Nigella sativa belongs to the Ranunculaceae family is an annual plant which distributed in southern Europe and some parts of Asia, including Syria, Turkey, Saudi Arabia, Pakistan, and India. Different active pharmaceutical ingredients have been identified in the N. sativa seeds, including saponins, flavonoids, cardiac glycosides, thymoquinone, thymol, limonene, carvacrol, p-cymene, alpha-pinene, 4-terpineol, longifolene, t-anethole benzene, isoquinoline, and pyrazole alkaloids, as well as unsaturated fatty acid such as linoleic acid, oleic acid, and palmitic acid.

Thymoquinone is the major bioactive ingredient, accounting for 30-48% of the essential oil, has high antioxidant and anti-inflammatory, immune-boosting, cell survival-improving, and energy metabolism-promoting properties, which may explain why they are so beneficial to our health. The anti-inflammatory properties of black seeds and thymoquinone are primarily mediated by COX-2 and PGD2 inhibition.

Clinical trials on skin disorders have shown that N. sativa essential oil and crude extract are effective. (Atopic dermatitis, Atopic eczema,Wart, Eczema, Acne vulgaris, Acute cutaneous leshmaniasis, Arsenical keratosis, Psoriasis, Vitiligo, Infant skin infections, Acute radiation dermatitis) It can be applied as an alternative treatment that helps patients with skin-related problems

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of mild psoriasis vulgaris
* Age: between 18 and 60 years' old
* Patients who stopped any systemic therapy or phototherapy for at least 3 months and topical therapy for at least 4 weeks prior to enrollment

Exclusion Criteria:

* Psoriasis vulgaris involving \> 10% of the body surface area, pustular or erythrodermic psoriasis.
* Pregnant or lactating females.
* Patients with any current dermatological disease.
* Patients with any current systemic disease.
Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty

The efficacy of using self-adhesive silicone gel waterproof dressings versus conventional gauze dressings for recovery after total joint arthroplasty (TJA) remains unclear. In our study, we conducted a prospective, randomized controlled trial to compare these two types of dressings. Patients were divided into two groups following TJA, and we collected primary outcome measures such as skin infection rate and re-operation rate. Additionally, we gathered blood inflammatory indicators, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), to evaluate the effectiveness of the two treatments. Finally, we perform one year follow up including REEDA score, MSS score to evaluate the recovery of the skin.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Meet the diagnostic criteria for artificial joint replacement;
3. Initial joint replacement surgery;
4. Voluntary and signed informed consent.

Exclusion Criteria:

1. Allergic to self-adhesive silicone rubber waterproof dressing;
2. Patients with severe knee joint infection who cannot undergo artificial joint replacement;
3. Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
4. periprosthesis infection after multiple joint replacement;
5. Active infection at the site of intravenous or joint injection;
6. long-term use of anticoagulants or antiplatelet drugs due to other diseases;
7. Have sepsis or positive blood culture within the last 30 days;
8. Radiotherapy and chemotherapy are required due to neoplastic diseases;
9. Receiving systemic glucocorticoid therapy (prednisone \> 10mg/ day or equivalent hormone medication);
10. severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
11. Have a history of drug abuse;
12. Treatment of bone marrow or other transplants with immunosuppressive drugs;
13. Pregnant, parturient and lactating women;
14. Participating in other clinical trials;
15. Researchers believe that other reasons are not appropriate for clinical trial participants.