cyrilzakka/clinical-trials huggingface dataset:
Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence

Regular follow-up is essential to successful management of congenital ectopia lentis, but it is often ignored by parents in China.

With rapid economic development, there are increasing numbers of mobile phone users that allow for communication applications to be used in medical care.

The investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

Congenital ectopia lentis is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, severe visual impairment is common in congenital ectopia lentis patients in China, and delayed presentation to hospital and late surgical treatment are found to be the major reasons.

In China, the messaging application WeChat has become the most popular communication tool. As most congenital ectopia lentis patients' parents are younger people, they are more likely to use technology, such as WeChat, in their daily lives. In addition, it allows ophthalmologists to utilize this communication application to relay health related information and reminders to patients. This makes it feasible to apply this smartphone application in improving attendance of follow-up visits.

In this trial, the investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Identified with congenital lens dislocation after surgery and age ≤ 18 years old; 2. Parents were able to access a mobile phone and communicate via the smartphone application (WeChat); 3. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

* 1. With Other ophthalmic diseases such as glaucoma, uveitis and corneal disease.
Fenoldopam for Prevention of Acute Kidney Injury

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.

The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.

Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.

The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.

Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.

Primary End-points

• Incidence of contrast induced acute kidney injury

Secondary End-points

• Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value

Eligibility Criteria:
Inclusion Criteria:

* Indication to urgent/emergency coronary angiography
* Normal renal function (eGFR\> 60 ml/min/1.73 m2)
* Moderate or high Mehran's risk score for CIN (\>11).
* Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. An additional purpose is to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naive macular degeneration patients with choroidal neovascularization
* \>50 years old
* Visual acuity 20/40 to 20/320

Exclusion Criteria:

* Pregnancy
* Previous history of thromboembolic event including myocardial infarction or stroke
Multi-model Image of Doxycycline in TAO

This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image.

Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. Different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in TAO. The improvement of exophthalmos is usually measured with Hertel instrument and the change of eyelid is measured with millimeter ruler. All these measurements are subjective, low reliable and less accurate.

TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. But still a progression and reoccurrence can be a big challenge for ophthalmologists. This is a perspective cohort study to evaluate the efficacy of doxycycline in TAO by multi-model image.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18-70 years old
* Diagnosed with TAO

Exclusion Criteria:

* Sight-threatening TAO with dysthyroid optic neuropathy
* Allergy of tetracycline
* Have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination)
Cost-effectiveness of Home Respiratory Polygraphy

Primary objectives:

The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale;

Secondary Objective:

1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.
2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques

Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques

Eligibility Criteria:
Inclusion criteria:

1. Snoring or sleep apneas observed by partner
2. Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10
3. Age between 18 and 70
4. Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness

Exclusion criteria:

1. Psycho-physical inability to complete questionnaires
2. documented structural or coronary cardiopathy not controlled by medical treatment
3. Cheyennes-Stokes Syndrome
4. Patient has undergone an uvulopalatopharyngoplasty
5. Unable to provide informed consent
A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva

The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period.

Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older at the time of enrollment, and not older than seventy years.
2. Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment).
3. Root coverage is not desired or indicated at the time of grafting.
4. Females of childbearing potential must have a documented negative urine or serum pregnancy test.
5. Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
6. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

1. Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface.
2. Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
3. Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
4. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
5. Subjects who smoke.
6. Teeth requiring treatment are molars.
7. Teeth with axial mobility.
8. Known hypersensitivity to bovine collagen.
9. Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks.
10. Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental).
11. Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s).
12. Subjects who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Epidemiological Landscape of Cervical Cancer in Latin America

A portrait of clinical and epidemiological aspects of cervical cancer in Latin America is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. A better understanding of the current situation of this scenario will provide a valuable groundwork for the development of national and cooperative programs to improve cervical cancer prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years.
* Histologically proven cervical carcinoma
* Diagnosis of carcinoma of the cervix since January 2018 or newly diagnosis or recurrent disease during the period of study recruitment.
* Any histology of cervical cancer at time of diagnosis.
* FIGO stage IB2-IVA
* Have available and adequate medical records for data collection
* Accept to participate in the project and sign the informed consent (if applicable)

Exclusion Criteria:

* FIGO stage I and IB1
* Non-invasive cervical cancer
* Synchronous tumor or second primary tumor in the last five years (exception for thyroid cancer or skin cancer non melanoma)
The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers

The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included. The volunteers will be randomized into one of 10 groups, each of 10 participants, consuming either active product in various mixes and doses (9 groups) or placebo product (1 group) for 2 weeks. The 9 groups receiving active product will receive either one of two Human Milk Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of the study is establishing the effects of various compositions and doses of HMOs on the faecal flora and on gastrointestinal symptoms in health adults.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Ability and willingness to understand and comply to the study procedures

Exclusion Criteria:

* Participation in a clinical study one month prior to screening visit and throughout the study.
* Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
* Any gastrointestinal symptom scored \>3 on the GSRS during the screening period
* A mean score on the total GSRS \>2 (i.e. above the population norm value) during the screening period
* Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
* Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
* Severe psychiatric disease, as judged by the investigator.
* Use of highly dosed probiotic supplements (yoghurt allowed) 3 months prior to the study and throughout the study.
* Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
* Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Lack of suitability for participation in the study for any reason as judged by the investigator.
Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health

Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities

Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI (18.5-29.9)
* Body weight ≥110 pounds

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Smokers
* Diabetic
* Heavy drinkers
* Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score \<26),
* Inability to understand the cognitive function tasks
* Intake of medication that might influence the outcome of the study (e.g. psychostimulant)
* cannabis product user
* Clinically diagnosed mental illnesses
* Cardiovascular and neurological disorders
* Uncontrolled hypertension
National Children's Food Survey II

The overall objective of this project is to establish for the Republic of Ireland (ROI) a nationally representative database of food consumption in children aged 5-12 years to update 2003-04 data for this group and to complement more recent data on preschool children and adults. The survey will be comparable with existing survey data in ROI and with surveys in UK (GB \& NI). The ROI database will be designed to address both nutrition and food safety issues of relevance to the development and implementation of public health policy, food safety risk assessment and to the needs of the food industry. In addition to detailed data on food consumption, data will be also be collected on body weight, lifestyle, including physical activity, determinants of food choice, urine, and composition of foods and food recipes. Food composition databases will be updated and restructured to facilitate future analyses of food ingredients, packaging materials, residues, contaminants, allergens, bioactives and microorganisms. Urine samples will be stored to facilitate future analyses nutrition and metabolic indicators, markers of food intake and for estimating exposure to food chemicals. Data will be analysed to estimate intakes of foods and nutrients and compliance with dietary recommendations, to establish the prevalence of overweight and obesity, to investigate physical activity patterns and compliance with guidelines, to identify psychological, social and attitudinal determinants of food choice and eating behaviour. Salt intake will be estimated from urine excretion. Findings will be disseminated to relevant stakeholders. The project will be carried out by a multi-disciplinary research team with strong linkages to related on-going research in food and health sciences.


Eligibility Criteria:
Inclusion Criteria:

* Attending primary school

Exclusion Criteria:

-
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.

The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation. Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.

Eligibility Criteria:
Inclusion Criteria:

* women from the age of 25 up to 40
* Serum-FSH and serum-LH levels under 12 IU/L
* Length of period between 25 and 34 days
* BMI between 18 and 30

Exclusion Criteria:

* less than 2 ovaries
* uterine abnormalities
* PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary