cyrilzakka/clinical-trials huggingface dataset:
Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases

The purpose of this study is to investigate the role of intravitreal injection of anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of ophthalmological neovascular diseases, in order to find a new strategy of treatment for ophthalmological neovascular diseases

Ophthalmological neovascular disease is one of the major causes of blindness in ocular diseases. Up to now, the major treatment strategies include: anti-VEGF therapy, laser therapy and surgery. Clinical treatment have revealed that intravitreal injection of anti-VEGF can effectively restrain neovascularization. Nevertheless, it requires repeated injections, may result in various complications, and may be ineffective in some patients. Therefore, it is necessary to find out other targets which causes retinal neovascularization, in order to find more effective treatments for patients who fail to respond to anti-VEGF therapy. Previous researches have shown that herb monomer (ACM-1) was effective in inhibiting leakage of retinal vessels and neovascularization. So in this study, patients with ophthalmological neovascular diseases will be treated with intravitreal injection of ACM-1, in order to investigate the role of intravitreal injection of ACM-1 therapy in prevention and control of ophthalmological neovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

1. age range from 18 to 75 years old
2. without light perception (NLP)
3. A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball
4. The best corrected visual acuity of the contralateral eye is better than 0.05
5. Follow-up for more than six months
6. Volunteer for this project and sign the informed consent

Exclusion Criteria:

1. The best corrected visual acuity of the contralateral eye is lower than 0.05
2. Severe systemic disease or other surgical contraindication
3. history of antiangiogenic therapy within one month
4. Ocular neovascularization was caused by other reasons,such as endophthalmitis
5. history of joining in drug clinical trial within one month(except for vitamins and minerals)
6. pre-menopausal women who do not use birth control
7. people are currently being treated for systemic infections
8. Allergic to fluorescein
9. hypertension(SBP is higher than 140mmHg)
10. hepatic renal dysfunction
11. History of drug abuse or alcoholism
12. other situation which will impede the clinical trial, as such depressive disorder
13. the compliance is too poor to finish the clinical trial
Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC)

Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis supplying the drug to close contacts of confirmed cases.

This is a randomized, double-blind, and controlled clinical trial that aims to evaluate the use of oral ivermectin in COVID-19 prophylaxis. The study has two arms in a relationship of 2:1: Experimental Group (EG n=500) and Placebo Group (CG n=250).

The sample size was calculated by applying a two-proportion comparison test. Type of two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% P1 (proportion in the placebo group), 65% P2 (proportion in the new treatment or intervention group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724 sample adjusted for losses.

The hypothesis of the study is that treatment with ivermectin may decrease the chance of occurrence/progress of clinical manifestations and onset of severe disease. Whereas control of the contagion on the first days of development of the disease, this treatment with ivermectin in suspected cases of COVID-19 (by epidemiological nexus) would contribute to the control of contagion at the first part of the infection, even in the absence of symptoms.

Categorical variables will be represented with frequencies and proportions, while continuous quantitative variables will be expressed as mean ± standard deviation (SD) or as median and interquartile range (IQR). The proportions will be compared using Pearson's Chi-square test or Fisher's exact test as appropriate, and continuous quantitative variables with Student's t test. The estimation of the efficacy of intensive treatment with Ivermectin will be calculated using Kaplan-Meier curves and the differences will be analyzed by means of the log-rank test. The risk will be calculated as a ratio of advantages for Intensive treatment with Ivermectin (Odds Ratio, OR) with its 95% confidence intervals (95% CI). A value of p \<0.05 will be considered significant. Analyzes will be performed using Stata 11.2 software.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years either sex
* Women of childbearing age with a negative pregnancy test
* In close contact group or epidemiological nexus of a positive COVID-19 case
* Able to understand and grant informed consent
* Real-time - polymerase chain reaction test with a negative result

Exclusion Criteria:

* Known hypersensitivity or allergy to any component of the drug under evaluation
* Age under 18 years
* Use of immunosuppressants (including systemic corticosteroids) in the last 30 days
* Pregnant or lactating
* Patients with other acute infectious diseases
* Patients with autoimmune disease and/or chronic decompensated diseases
* Who have received a vaccine for COVID-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another COVID-19 prophylaxis study
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases

The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome.

Secondary objectives are to compare expression and methylation profiles according to:

* treatment response
* morphological (endoscopic and/or radiological) and clinical post-operating recurrence.

This aim of this study is to search for new biomarkers predictive of post-operating recurrence.

At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data.

Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies...), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data
* Patient undergoing ileocolic resection
* Patient affiliated to French social security

Exclusion Criteria:

* Patient refusing sampling
* Patient with undetermined colitis
* Patient with non-confirmed diagnosis of inflammatory bowel disease
* Patient with inflammatory bowel disease not undergoing ileocolic resection
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
* Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
* Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

* Have a treatable cause of seizures
* Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
Early Prostate Cancer: Predicting Treatment Response

This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.

The study will contribute a replicable model for improving risk prediction from patient characteristics, clinical severity indicators, and genomic tests to aid in personalizing treatment. The proposed registry would also allow future comparisons of the gene expression used in other competing commercial test. The addition of the suggested genomic classifier and its associations with other patient and clinical characteristics will enhance the ability of future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness in prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 90 years of age
* Prostate-Specific Antigen (PSA) values \<50ng/ml
* Clinical stage of T1 or T2
* No evidence of metastasis or nodal involvement

Exclusion Criteria:

* Age 91 or greater
* Clinically locally advanced or metastatic disease
* PSA equal to or greater than 50ng/ml
* Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up

patients 6-25 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls.

upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history.

blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification only for patients with IBD.


Eligibility Criteria:
Inclusion Criteria:

* IBD or celiac patients with a confirmed diagnosis, recruited upon diagnosis.
* Both male and female
* Age 6-25 years
* Medically treated for IBD in our institute.

Exclusion Criteria:

* Genetic disorder.
* Known primary or secondary immunodeficiency .
* Pregnancy or lactating
Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)

The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.

Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of Adolescent Idiopathic Scoliosis
* Risser 0-2
* Cobb Angle between 20 and 40 degrees
* Prescription for a brace
* Able to understand French or English

Exclusion Criteria:

* Grade II or higher Spondylolisthesis
* Neuromuscular disease
* Past spinal surgery
Primary Health Care Delivery Models in Conflict Settings of Cameroon and Nigeria

The overall objective of this research is to understand the PHC landscape in conflict-affected settings including choice of PHC delivery models and quality interventions used by humanitarian organisations

There is sparse evidence to guide the selection and design of primary health care (PHC) services that improves and maintains quality care in humanitarian settings. The Northwest and Southwest regions of Cameroon, and Northeast Nigeria have protracted humanitarian crises. Various models of PHC are used in these settings; ensuring quality of PHC models of care is essential to improve health outcomes. We aim to explore how PHC models are selected by humanitarian organizations and through stakeholder engagement design a toolkit for evaluation of quality in PHC care delivery across different models.

The specific objectives of the study are;

1. To map different primary health care delivery models used by public, private and humanitarian organization in the conflict affected settings of NWSW Cameroon and North East Nigeria by conducting a mapping survey
2. To explore the factors influencing the selection of primary health care delivery models used by humanitarian organizations to guide the selection of models of care and strengthening of programming efforts in conflict settings by conducting an exploratory qualitative study
3. To determine the coverage and gaps in services across the different PHC models to develop a pilot questionnaire to evaluate quality in conflict settings by conducting an exploratory qualitative study

The humanitarian crisis in North West and South West regions of Cameroon and North East Nigeria, has led to the closure of 269/933 and 617/2367 health facilities respectively with over 2.21 million IDPs and 350,000 returnees(2, 3), creating a huge gap in the availability and accessibility of health services to affected communities. The need to conduct this study becomes even more pertinent to inform program developers and donors on key considerations to make before using different models of care, and how quality can be improved to foster sustainability

Eligibility Criteria:
Inclusion Criteria:

* Male and female staff of humanitarian organisations, internally displaced persons (confirmed to be a resident of an IDP or host community);
* Age 21 years of age or older;
* Ability to provide informed consent or assent to participate in the research

Exclusion Criteria:

* Individuals who are mentally ill or with limitations to communicate well;
* Those who cannot speak or understand the local languages so that they cannot understand the interviewer.
* Those who refuse to provide consent to the study or who do not want to participate in the study
The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management

The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.

The study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.The population of the study consists of 141 adolescents aged 13-18 diagnosed with Type 1 diabetes, who are being followed up at the Diabetes Education Unit of Evliya Çelebi Training and Research Hospital, affiliated with Kütahya Health Sciences University in the province of Kütahya, Türkiye. The sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. In their research, where motivational interviews were used for adolescents' diabetes management, the reported HbA1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 1 diabetes at least 6 months ago
* Under follow-up at Kütahya Evliya Çelebi Health Sciences University Training and Research Hospital Diabetes Education Unit
* Having an HbA1c level above 7.5% in the most recent measurement
* Having a smartphone

Exclusion Criteria:

* Refusal of legal guardian or the adolescent themselves to participate in the research
* Difficulty in communication or answering questions
* Having hearing, speech, vision, or cognitive impairments
* Being in the honeymoon period of Type 1 diabetes
* Having a second autoimmune disease, such as celiac disease, besides Type 1 diabetes
Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)

The purpose of the study is the identification of chromosomal aberrations in urine samples.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples.

The FISH test detect chromosomal aberrations in urine specimens from persons with hematuria suspected of having bladder cancerous using the UroVysion® Bladder Cancer Kit (UroVysion Kit) which is FDA approved. This kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Well stained slides with bright FISH signals

Exclusion Criteria:

* Very old slides that were already bleached
Clinical-Genetic Variation in GABA/Alcohol Sensitivity

The purpose of the study is to better understand how genetic factors influence individual sensitivity to alcohol.

We want to find out if there are specific characteristics of a person's genes which will cause them to respond differently to alcohol. Genes are parts of the chromosomes found in the cells of our bodies which control our physical characteristics such the color of our hair, eyes, and other features. Genes are made up of molecules called "DNA" which carry the genetic information we receive from our parents. Just as genes control our physical characteristics, differences in genetic information may also explain why some people are more sensitive to alcohol or have problems drinking too much.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female with at least one Hispanic birth parent of Mexican ancestry, 21-25 years of age, and able to read the English-language consent form.
* The subject self-reports current use of 3-30 standard drinks
* The subject is in good physical health as determined by history, physical and laboratory studies of hematology and chemistry
* The subject has a Body Mass Index (BMI) between 20-28
* The subject is not concurrently using psychoactive medication or illicit drugs
* If subject is female, she is not pregnant (determined by weekly urine pregnancy screens), is practicing barrier or chemical methods of birth control, and not nursing babies

Exclusion Criteria:

* The subject meets DSM-IV criteria for any lifetime history of alcohol dependence, or dependence or abuse on any other drug in the past two years excepting tobacco dependence
* The subject currently meets DSM-IV for any other psychiatric (Axis I) disorder, excepting tobacco dependence
* The subject cannot consistently provide alcohol-free breath samples and drug-free urine samples
* The subject uses \> 20 cigarettes per day or \> 500 mg caffeine per day
* The subject's physical exam, lab tests, and medical histories indicate medical illness requiring treatment or interacting with the alcohol or benzodiazepine treatments
* The subject has a sleep apnea or narrow angle-glaucoma (contraindications for benzodiazepines)
* The subject reports extreme hypersensitivity or allergic reactions to benzodiazepines or unusual hypersensitivity to multiple medications
* The subject is unwilling or unable to consent to all experimental procedures including confidential family history interviews and genetic testing specified by the protocol
Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.


Eligibility Criteria:
Inclusion Criteria:

* You are male and aged at least 18 years.
* Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
* Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
* You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
* Your entry laboratory test results and medical tests meet study requirements
* You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
* If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria:

* You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
* Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
* You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
* Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
* Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Outcome of Different IOLs in Patients With and Without Uveitis

Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.

Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.

The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis


Eligibility Criteria:
Inclusion Criteria:

* Cataract requiring surgery
* Ability to understand and sign consent form

Exclusion Criteria:

* Extensive corneal scarring
* Other eye surgery less than 3 months before inclusion
* Unregulated glaucoma
* Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
* Intraoperative complications (capsular tear or vitreous loss)