cyrilzakka/clinical-trials huggingface dataset:
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of VMT/sVMA, with evidence of focal VMT visible on Spectral Domain - Optical Coherence Tomography (SD-OCT).
* Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
* Willing and able to attend all study visits.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Hypersensitivity to ocriplasmin or any of the JETREA™® excipients.
* Active or suspected intraocular or periocular infection in either eye.
* Participation in any interventional clinical trial within 30 days prior to baseline.
* Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
* Broad VMT/VMA \> 1500 microns at baseline in the study eye.
* History of vitrectomy in the study eye.
* History of laser photocoagulation to the macula in the study eye.
* Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period.
* Macular hole of \> 400 microns diameter in the study eye.
* High myopia in the study eye.
* Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability.
* Aphakia in the study eye.
* History of retinal detachment in the study eye.
* Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy).
* Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.
* Retinal vein occlusions in the study eye.
* Exudative age-related macular degeneration (AMD) in the study eye.
* Vitreous hemorrhage in the study eye.
* Other protocol-specified exclusion criteria may apply.
Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy

Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Periodontitis stage III-IV
* Full-mouth plaque score (FMPS) \< 25% at the 1-month re-evaluation
* Full-mouth bleeding score (FMBS) \< 25% at the 1-month re-evaluation
* Signed informed consent

Exclusion criteria

* Age \< 18 yo
* Pregnancy or lactation
* Heavy smokers (\>10 die)
* Conditions or diseases influencing periodontal healing
* Patients that cannot complete the 6 months follow-up
Sharp Versus Blunt Fascial Incision at Caesarean Section

The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:

1. The preferred side evaluated by the patient 3 months postoperatively.
2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.
3. The rate and side of infection.


Eligibility Criteria:
Inclusion Criteria:

* Woman having caesarean section for the first time
* Woman, who have had no previous lower abdominal surgery
* Woman who speak and understand Danish
* Woman who can give informed consent

Exclusion Criteria:

* Diabetes Mellitus (This does not include gestational diabetes)
* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18 years old
* Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
* BMI over 35
Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty

To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).

Since 2006, the technique by removing the Descemet membrane from the recipient cornea was renamed Descemet stripping automated endothelial keratoplasty (DSAEK). In recent years, DSAEK techniques have evolved, favoring increasingly thinner and finer grafts, known as ultrathin DSAEK (UT DSAEK), with the aim of obtaining better visual results.

Endothelial keratoplasty is now the most common surgical procedure used to treat endothelial dysfunction. The current study focused on assessing both objective and subjective visual quality outcomes following DSAEK.

Eligibility Criteria:
Inclusion Criteria:

* Clinical eligibility for DSAEK
* Informed written consent
* Successful completion of DSAEK procedure
* Postoperative follow-up at least 1 year
* Ability to respond to the questionnaire

Exclusion Criteria:

* Patients with clinical edematous cornea
* With significant stromal opacity
* With major disturbances of ocular surface
* Previous corneal surgery
Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity

The goal of this observational study is to learn about the effects of early-life adversity (ELA) on the composition of children's microbiome and on their psychosocial functioning. The main questions it aims to answer are:

* Do children who have experienced ELA have lower gut microbial diversity and/or an altered gut microbial composition?
* Do these microbiome alterations correlate with adverse neurodevelopmental outcomes, including increased levels of stress, social and/or affective problems?


Eligibility Criteria:
Inclusion Criteria:

* Primary school-aged children (6 to 13 years of age) who have experienced at least one early-life traumatic event, based on the Childhood Trust Events Survey (CTES) questionnaire
* The child and at least one of his/her parents (or guardian) speak Dutch sufficiently well to complete all of the questionnaires and the semi-structured child psychiatric interview (SCID-5-Junior)

Exclusion Criteria:

* any chronic disorders or diseases known to affect the gut micobiome
* inablity to complete questionnaires and/or semi-structured interview because of linguistic and/or cognitive barrier
* congenital or acquired immunodeficiencies
* use of medication(s) that affect gastrointestinal function (e.g., antibiotics) within the last 6 weeks, or laxatives within the last 4 weeks, or probiotic or prebiotic supplements within the last 4 weeks
* current involvement in another clinical or food study
Familial Prostate Cancer

The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Eligibility Criteria:
Families will be identified with two or more first degree relatives affected with prostate cancer or with one male with prostate cancer that developed before age 55.

Must have clinical evidence of prostate cancer in the family.
Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients With Hereditary Cancer Syndromes

This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.


Eligibility Criteria:
Inclusion Criteria:

* PROBANDS: Clinically confirmed autosomal dominant pathogenic germline variant (PGV) associated with a hereditary cancer syndrome
* PROBANDS: Previous evaluation by the University of Michigan (U-M) Cancer Genetics Clinic
* PROBANDS: ≥ 18 years old
* PROBANDS: Able to speak and read English
* PROBANDS: Access to the internet
* RELATIVES: Biological relative of proband
* RELATIVES: ≥ 18 years old
* RELATIVES: Able to speak and read English
* RELATIVES: Access to the internet
* RELATIVES: Have not completed germline genetic testing, per self-report at baseline

Exclusion Criteria:

* RELATIVES: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline
Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum

The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected.


Eligibility Criteria:
Inclusion Criteria:

* All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy.

Exclusion Criteria:

* Anyone \< 18 years of age.
* Multiple synchronous primary malignancies from different organ systems.
Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain).

This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk.

The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the ADR card, return for the next scheduled visit or return the ADR card by mail within a timely manner).
* A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December 2018.
* Subjects aged 6 months or above at the time of the vaccination according to the countries' specificities.
* Written informed consent/informed assent obtained from the subjects/subjects' parent(s)/Legally Acceptable Representative(s) (LARs).

Exclusion Criteria:

• Child in care.
A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* a history of kidney stones
* self-reported pregnancy or nursing
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma

Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid tumours. acute renal failure, despite conservative fluid and electrolyte management, frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor, vascular endothelial growth factor and insulin-like growth factor-I have shown in the previous in-vitro studies.The aim of present study,a randomized double-blind placebo- controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus chemotherapy \[cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21 days\] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine electrolyte will be measured daily during chemotherapy.

changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity assessed up to 64 days.

This study will look for possible protective effects silymarin on kidney injury in patients receiving cisplatin.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* diagnosed
* measurable upper gastrointestinal adenocarcinoma
* swallow problem
* would like to participate in the study
* Glomerular filtration rate(GFR)\>45ml/min/1.73m2

Exclusion Criteria:

* end stage renal disease
* requiring dialysis
* post transplantation
* receiving contrast media during last 72 hours
* chronic use of corticosteroids
* chronic use of angiotensin-converting enzyme inhibitor(ACEI )
* untreated hypo-and hyperthyroidism
* ejection fraction\<60%
* active urinary tract infection
* iver disease ( five fold increase of liver enzyme in asymptomatic or 3 fold increase in symptomatic
* use of other nephrotoxic agents such as aminoglycoside, amphotericin
* karnofsky performance status \<70
Evaluating Patients With Abnormal Levels of Gastric Acid

This study is used by the Digestive Diseases Branch to evaluate patients with suspected abnormalities in the secretion of gastric acid. The level of gastric acid is measured by analyzing the gastric juices of each individual patient. The gastric acid sample is obtained by a procedure known as nasogastric suctioning, where a thin plastic tube is passed from the nose to the stomach.

Depending on the patient's present condition further diagnostic testing may be required to achieve a diagnosis.

This study is an omnibus protocol used by the Digestive Diseases Branch to evaluate patients with suspected abnormalities of gastric acid secretion. Gastric acid secretion is measured by means of analysis of gastric juices obtained by nasogastric suction. Other clinically indicated diagnostic procedures are performed depending on the patient's clinical state in order to reach a diagnosis.

Eligibility Criteria:
Eligibility criteria not identified in the protocol.
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).

This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children \< 5 years of age, conducted in four hospitals located in four Brazilian regions. A stool sample from each eligible child passing 3 or more loose stools or watery stools within a period of 24 hours and requiring hospitalization or rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus, using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by all participating hospitals.


Eligibility Criteria:
Inclusion Criteria:

* a child \< 5 years of age being treated for acute gastroenteritis within 72 hours prior to evaluation in the study hospitals.
* outpatient children \< 5 years of age submitted for treatment of acute gastroenteritis within 72 hours prior to evaluation in the study clinics.

Exclusion Criteria:

* none specified
New Causes and Predictors for the Development of Atrial Fibrillation and Its Complications

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence increases with aging of the population. It is reflected in the ECG recording by the replacement of regular P-waves by an undulating baseline and irregular ventricular complexes \[2\]. The uncoordinated atrial activity prevents effective atrial contraction, leading to clot formation. Atrial fibrillation contributes significantly to population morbidity and mortality, and presently available therapeutic approaches have major limitations, including limited efficacy and potentially serious side effects. It can be classified into one of the three following categories:

1. Paroxysmal: self-termination within 7 days
2. Persistent: requires termination by pharmacological or direct-current electric cardioversion
3. Permanent: restoration to sinus rhythm is impossible or inadvisable

It is believed that in many cases the natural history of AF involves evolution from paroxysmal to persistent to permanent forms through the influence of atrial remodeling caused by the arrhythmia itself and/or progression of underlying heart disease. As many underlying conditions contribute to the development and progression of AF, the full and exact mechanisms standing behind this common arrhythmia are not completely or sufficiently understood.

Thromboembolism is by far the most important complication of AF, and the most common factor in stroke in the elderly. The determinants of Virchow triad, including stasis, endothelial damage, and coagulation properties, are centrally involved in AF- related thrombus formation.

Hence, thorough searching for new possible causes or contributing factors for the developing and progression of AF and its most threatening complication, thromboembolism, is mandatory

The aim of the study is to look for new possible causes of atrial fibrillation and its complications.

This is an observational historical prospective study. All patients admitted to the Rambam health care campus between 1.1.2007 and 31.11.2011 with the primary diagnosis with Acute Atrial Fibrillation and were 18 years old or older at the time of diagnosis, will be included in this historical prospective study.

Patients' demographic data, medical history, permanent medications, laboratory studies, electrocardiographic and echocardiographic reports will be collected from the radiologic information system; a computed medical registry.

After collecting the data, statistical analysis will be performed aiming to discover possible causes or predictors for atrial fibrillation development and the occurrence of its adverse complications, especially thromboembolism.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis with Acute Atrial Fibrillation
* 18 years old or older at the time of diagnosis
* admitted between 1.1.2007 and 31.12.2011

Exclusion Criteria:

-
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea

This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital


Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnose with Obstructive sleep apnea 18-65 years

Exclusion Criteria:

* BMI\>=35kg/m2
* alcoholic and smoke
* use sleeping pill
* craniofacial syndrome
* hypertrophic tonsils grade 3+, 4+
* severe comorbidity
* Use CAP