cyrilzakka/clinical-trials huggingface dataset:
Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.

GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)

0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, \> 4: Diagnostic of intraocular antibody production to a specific microbial pathogen

Eligibility Criteria:
Inclusion Criteria:

* Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis

Exclusion Criteria:

* Immunocompromised patients
Evaluation of the Health Related Quality of Life and Disease Prevalence of Children From Spain at 6-8 Years of Age Who Participated in a Qualifying Infant Formula Study at Birth

The purpose of this study is to evaluate the influence of the type of feeding in the first year of life on the behavior and health-related quality of life at 6-8 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Father, mother or legal representative of a child who was included in the qualifying study
* Child 6 - 8 years of age
* Written informed consent of the father, mother or legal representative

Exclusion Criteria:

* None
Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps

The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.


Eligibility Criteria:
Inclusion Criteria:

* Provision to sign and date the consent form
* Stated willingness to comply with all study procedures and be available for the duration of the study
* Be a male or female aged 18-89
* Undergone colonoscopy
* At least one advanced colorectal polyp, defined as having any of the following:
* Any polyp ≥ 1cm (adenoma or serrated polyp)
* Any polyp with villous architecture
* Any polyp with high-grade dysplasia
* Sessile serrated polyps with any dysplasia
* Traditional serrated adenoma

Exclusion Criteria:

* Known hereditary cancer syndrome
* Personal history of inflammatory bowel disease
* Personal history of colorectal cancer
* Polyp histology or size unavailable or not documented
Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for cerebral small vessel disease.
* Dysphagia confirmed by Videofluoroscopic Swallowing Study
* Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease.
* Neurological blockade contraindications such as bleeding tendency, blocked site infection.
* Unable to successfully finish the assessment of this study.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy

The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
* Use of protocol specified methods of contraception

Key Exclusion Criteria:

* Current or prior history of clinically significant illness that may interfere with participation in the study
* Screening ECG with clinically significant abnormalities
* Laboratory parameters outside the acceptable range at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Tannin Specific Natural Extract for COVID-19 Infection

There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.

The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.

Tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and a regulatory effect on the gastrointestinal metabolism.

The investigators will realize a prospective, double-blind, randomized trial to assess the effect of treatment with a dietary supplement (ARBOX), a molecular complex of quebracho and chestnut tannins extract and Vit B12, compared with placebo. 140 COVID-19 patients will be recruited in a single center in Buenos Aires Argentina. 70 patients will receive conventional treatment plus ARBOX (treated group) and 70 patients will receive conventional treatment plus placebo (control group). The effects will be evaluated during the 28 days follow up. The primary end point will be the time of discharge from the hospital. A panel of 27 cytokines level, intestinal microbiota composition and its metabolites will be assessed at day 1 and 14.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age hospitalized in the general hospitalization room, who meet the definition of "Confirmed case COVID-19" (https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion -of-case)

Exclusion Criteria:

* Pregnancy
* Lactancy
* Hypersensitivity to polyphenols
* Patients unable to receive oral medication (severe cognitive impairment, assisted ventilation, impaired state of consciousness)
* Lack of consent
* Participation in any other interventional clinical trial
The Effect of Aromatherapy Before Clinical Practice on Stress, Anxiety and Depression in Midwifery Students

This study was planned as a randomized controlled study to determine the effects of petitgrain and ylang ylang oil applied before clinical practice on stress, anxiety and depression in midwifery students.


Eligibility Criteria:
Inclusion Criteria:

* Being a midwifery student

Exclusion Criteria:

* Having an asthma or any other respiration disease
* Trouble of smelling
* Allergies to petitgrain or ylang-ylang essential oil
Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones

Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.


Eligibility Criteria:
Inclusion Criteria:

1. Age above than 15 years
2. Renal stone(s) with total burden of 2 cm or less
3. Signature on written, informed consents with the details of this study requirements.
4. Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)

Exclusion Criteria:

1- asymptomatic bacteruria 2- active urinary tract infection (UTI) 3- uncorrected coagulopathy 4- current use of antiplatelet therapy 5- pregnancy

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Understanding Mechanisms of Exercise Behavior Change

This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with an active self-monitoring intervention condition in which no rewards are offered. Study participants will provide reports of their physical activity each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their physical activity. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.


Eligibility Criteria:
Inclusion Criteria:

* Complete less than 150 minutes of moderate-vigorous physical activity weekly
* Daily access to the internet for 3 weeks following baseline research visit
* Have or are willing to create an account on PayPal
* Willing to wear a heart rate monitor watch during physical activity for 3 weeks
* BMI greater than or equal to 25, from self-reported height and weight

Exclusion Criteria:

* Diagnosis of cardiovascular, metabolic, or renal disease
Gingival Margin Stability Following Esthetic Crown Lengthening Utilizing a Double Periodontal Surgical Guide

In patients with excessive gingival display, esthetic crown lengthening procedure by means of scalpel, diode laser or electro-surgery could result in the same gingival marginal stability at 3 and 6 months follow up.

Scalpel crown lengthening has been recommended as the gold standard for treating excessive gingiva. Two other established tools used for gingivectomy procedures are electrosurgery and lasers. Laser crown lengthening may have the advantages of less bleeding during the procedure, faster healing, and less pain following the procedure. Electrosurgery which involves the application of a high- frequency electric current to the gingiva has been shown to produce minimal bleeding, ease and speed of cutting and reduced postoperative pain. The null hypothesis that the three techniques for aesthetic crown lengthening (ACLP) would show equivalent gingival margin stability at 3 and 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* Altered passive eruption as presence of quadratic anterior teeth \[crown width/length ratio

  * 0.85 \].
* Gingival margin located coronal to the tooth cervical convexity and \>2 mm of gingival band display during maximum smile.
* Patients with treated periodontal disease (i.e., stage I of periodontitis);

Exclusion Criteria:

* Patients with systemic contraindications for oral surgery as uncontrolled diabetes.
* patients on drug therapy related with drug-associated gingival enlargement.
* Areas in which the remaining amount of keratinized gingiva after the submarginal incision is less than 3 mm.
* Previous surgical treatment in the same area.
Familial Atherosclerosis Treatment Study

To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.

BACKGROUND:

For several decades, clinical trials have addressed the question of whether treatment of hyperlipidemia reduces the risk of cardiovascular events. Substantial evidence supports the idea that cardiovascular benefits are related to the degree of reduction in low-density lipoprotein cholesterol level and perhaps to the degree of increase in the high-density lipoprotein cholesterol level. In these trials, changes in lipid levels have usually been small and the overall clinical benefits have been limited. The appearance in the 1980s of more effective treatments for hyperlipidemia, new arteriographic methods for assessing atherosclerosis, and new insights into atherogenesis permitted an objective investigation into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering agents.

The clinical trial was supported by a subproject within a program project grant.

DESIGN NARRATIVE:

Randomized, double-blind, placebo-controlled. Baseline arteriograms were performed and fasting lipid samples drawn before heparinization. Patients were stratified for age below 45 years, cigarette smoking within the previous month, and lipid patterns including familial hypercholesterolemia and triglyceride levels. Patients were given dietary counseling and randomly assigned to one of three treatments: lovastatin (20 mg twice a day) and colestipol (10 g three times a day); niacin (1 g four times a day) and colestipol (10 g three times a day): or conventional therapy with placebo (or colestipol if the LDL cholesterol level was elevated). The primary endpoint was a measure of change in the severity of disease in the proximal coronary arteries as measured by quantitative arteriography.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Age 62 or younger
* elevated apolipoprotein B levels
* coronary atherosclerosis
* family history of coronary heart disease.

Exclusion Criteria:

* diabetes
* severe hypertension
* cancer
* liver disease
* thyroid disease
* kidney disease
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

Standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. When complete reduction of the eviscerated contents is not possible, a silastic " silo" is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. Once reduction is obtained, the silo is removed and the abdominal defect is closed.

Current methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. The optimal timing and method of closure, including primary versus secondary closure, continues to be debated. No prospective randomized studies to date have examined the routine use of the spring-loaded silo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gastroschisis
* Birth Weight ≥ 1500 grams
* Gestational Age ≥ 34 weeks

Exclusion Criteria:

* Birth Weight \< 1500 grams
* Gestational Age \< 34 weeks
* Presence of Bowel Ischemia or Necrosis
* Abdominal wall defect too small
* Major associated anomalies or medical condition
* Presence of Intracranial Hemorrhage (grade IV)
* Parent Refusal for Randomization
Evaluation of Quality of Care - Risk Assessment Management Programme, HA

Diabetes mellitus (DM) is one of the major cause of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the risk assessment and management programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the RAMP for more than one year will be included in the evaluation on the process and outcomes of care.

One thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the RAMP programme will be selected for the comparison in the outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records.

Main Outcome Measures: The primary outcomes are the proportion of participants who have received the criterion process of care, and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC criteria will be calculated. The changes in the clinical and patient reported outcomes of RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. The clinical outcomes between RAMP subjects and control group will be compared by independent sample t-test or Chi-square test.

Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.

Conclusion: The results of this study will provide empirical evidence on whether the HA's RAMP programme can achieve improvement in QOC for DM patients. The information will be used to guide service planning and policy decision making.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DM who are mostly independent in their activities of daily living and being followed up at GOPC regularly will be recruited.

Exclusion Criteria:

* Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion

It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that.

The aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.

Isolated ankle fusion is normally regarded as a good operation producing good pain relief and allowing patients to function well. Patients will have an early heel rise when walking and although that is often not immediately perceptible to an onlooker, it does increase the stress on the neighbouring subtalar and Chopart joints. Radiologically, subtalar joint arthrosis is common following isolated ankle fusions but not necessarily clinically symptomatic. The long term incidence of subsequent ipsilateral subtalar or Chopart joint fusions is not well known. Various different studies have shown a prevalence of osteoarthrosis (radiologically) of 24-100% in the subtalar joint and reported 84% of patients complaining of pain after 10 years. The prevalence in the Chopart joints has been reported to vary between 18-77%.

This is an observational study reviewing medical records and radiology of patients who have had an isolated ankle fusion. The data will be analysed using basic statistics with logistic regression modelling.

Eligibility Criteria:
Inclusion Criteria:

Any patient who has had an isolated ankle fusion and is over the age of 18 years old.

Exclusion Criteria:

Participants younger than 18 years old.