cyrilzakka/clinical-trials huggingface dataset:
Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients

Background: The objective of corneal collagen crosslinking (CXL) is to increase the binding of intrafibrillary and interfibrillary covalent bonds to improve the mechanical stability of the cornea and thus to stop the progression of corneal ectasias. Although the vast majority of studies have described pain after photorefractive keratectomy (PRK), the pathophysiological principle of pain is similar in CXL. From the anatomical point of view, the corneal epithelium is the most densely innervated and sensitive surface of the body, being 300-600 times greater than in the skin. The pain after CXL comes from several routes, the process begins with the epithelial rupture that generates exposure of the nerve endings, induces apoptosis and necrosis of the epithelial cells. Subsequently an inflammatory cascade is initiated in which the different cytokines stimulate the nerve terminals. Inflammatory mediators also activate the ion channels in the nerve membrane, and this process continues until the epithelium heals. Additionally, exposure to UVA rays can also cause nerve damage. The effect of local cold for pain management has already been reported in PRK. By cooling the cornea, the release of chemical mediators and inflammation can be reduced. In the CXL radiation is transformed into several forms of energy: fluorescent radiation, chemical energy and, to a small extent, heat. The CXL process is energetically comparable to photosynthesis, in which the radiation energy is transformed into chemical energy (glucose) with the help of pigments (chlorophyll). The thermal effect is negligible in the photochemical method of CXL. Justification: No method for the control of pain after crosslinking is considered ideal or universally accepted, the importance of this study lies in looking for an additional tool to reduce the most common postoperative complaint in a highly performed procedure worldwide. Hypothesis: The application of riboflavin at 4oC reduces the pain assessment after the CXL. Purpose: to evaluate the effect of the application of riboflavin at 4oC in the assessment of postoperative pain in patients undergoing CXL. Materials and methods: Prospective and interventional clinical study in patients older than 18 years with a diagnosis of keratoconus who underwent CXL, in the cornea and refractive surgery service of the Ophthalmology institute Fundación Conde de Valenciana.


Eligibility Criteria:
Inclusion Criteria:

* patients of any gender
* older than 18 years
* diagnosis of keratoconus who require management with crosslinking in both eyes for evidence of progression.

Exclusion Criteria:

* crosslinking without removal of epithelium or unilateral crosslinking.
* patients with other ocular conditions different from keratoconus.
* cognitive disability that limits the compression of the pain test as Down syndrome, etc.
Effect Of Obesity On Ozone-Induced Airway Inflammation

The purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults.

Obesity has been shown to be associated with initial onset of asthma in children and increased airway hyperresponsiveness in adults (1,2). An important aspect of these epidemiologic data is that the impact of obesity on asthma is much stronger in females than males. For example, the incidence of asthma after the age of 11 years is five- to sevenfold higher in female children who become obese versus those who remain lean, whereas no such relationship exists for males (3). Recent mouse models of obesity suggest that this condition enhances airway responses to ozone air pollution (4). These mice eat excessively due to a defect in the gene encoding leptin, a satiety hormone produced in adipocytes. Shore et al (4) showed that these leptin-deficient obese mice had greater airway hyperreactivity to i.v. methacholine following ozone exposure compared to lean, wild-type mice. Furthermore, administration of exogenous leptin (which is actually increased in the serum of obese individuals (4)) was shown to enhance ozone-induced cytokine and protein release into BAL fluid of lean, wild type mice (4). Reduced lung volumes and altered breathing patterns in the obese may also contribute to enhanced airway reactivity in these patients (5). Stretch of airway smooth muscle during tidal breathing and especially during deep breaths, i.e. sighs, acts as a potent bronchodilator that might ameliorate ozone-induced bronchoconstriction. The increased chest load associated with obesity may also diminish tidal breathing volumes and frequency of sighs during ozone exposure.

Eligibility Criteria:
Inclusion Criteria:

* Twenty (20) non-obese, non-overweight (body mass index, 18 kg/m2 \> BMI \< 25 kg/m2, waist circumference \< 35 inches) subjects and 20 obese (30 kg/m2 \> BMI \< 38 kg/m2, waist circumference \>= 35 inches) volunteer females between 18-35 yrs of age

Exclusion Criteria:

* Are female and pregnant or have any reason to believe you might be pregnant.
* Are not between 18 and 35 years old.
* Have a history of asthma or have current hay fever.
* Have ever smoked more than 10 cigarettes (one half pack) a month or smoked during the past 30 days.
* Have a history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks.
* Have contraindications for performing sustained light exercise.
* You've been in a recent or recurring exposure to a dusty environment at work
* If you are unwilling to refrain from strenuous physical activity for 24 hours before and after each exposure.
The Effect of Lumify™ Eyedrops on Eyelid Position

The purpose of the research is to see if Lumify™ has an effect on eyelid position.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and above able to provide informed consent to participate
* Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion Criteria:

* Adults unable to consent
* Prisoners
* Pregnant women.
* Known contradictions or sensitivities to study medication (brimonidine)
* Ocular surgery within the past 3 months or refractive surgery within the past six months
* Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
* Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
* Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 \< 1mm)
* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
* Presence of an active ocular infection
* Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
* Inability to sit comfortably for 15 - 30 minutes
Methorexate and Knee Osteoarthritis

Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA.

128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores.

Keywords:

methotrexate knee osteoarthritis inflammation pain reduction physical funtion


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis
* synovitis
* pain

Exclusion Criteria:

* other inflammatory conditions
* hepatic insufficiency
* renal insufficiency
Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities

To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.

To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.

Eligibility Criteria:
Inclusion Criteria:

1. 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
2. impaired semen quality including sperm concentration \<15 million/ml or total motility \<40% or progressively motile \< 32% (a+b), the 5th edited World Health Organization criteria was referred;
3. with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
4. patient's spouse was healthy in reproduction.

Exclusion Criteria:

1. with subclinical varicocele, recurrent varicoceles;
2. normal semen analyses;
3. other reasons of infertility than varicoceles;
4. refusing to enter randomization;
5. female partner older than 35 years;
6. with abnormal level of serum hormones;
7. female factor infertility;
8. with significant surgical diseases, congenital diseases or endocrine diseases.
A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas

This is a surgical biospecimen collection study. The purpose of this study is to understand how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn off the RAF signaling pathway. This is important because these drugs are currently FDA approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation.

The primary goal of this study is to establish concentrations of dabrafenib and trametinib in enhancing brain tissue and cerebrospinal fluid from people with BRAF-V600E mutant recurrent gliomas who undergo tumor resection. The exploratory goals are to measure the amount of ERK signaling pathway activity, to identify mechanisms of resistance to these drugs, and evaluate feasibility of measuring tumor DNA in cerebrospinal fluid.

People (adults or children) with brain tumors who are already taking dabrafenib and / or trametinib and are in need of a surgical resection are potentially eligible. On the day of surgery, blood, cerebrospinal fluid, and tumor tissue will be collected for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
* Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
* Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician. Note: Pediatric patients may be taking any dose of dabrafenib and / or trametinib as prescribed by their treating physician for at least 7 days prior to surgery.
* Subjects must be undergoing surgery for clinical purposes.
* Written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation will be obtained according to institutional guidelines.

Exclusion Criteria:

* Subjects who are receiving any other investigational agents or chemotherapeutic agents.
* Subjects for whom collection of blood, spinal fluid, or tissue samples is unsafe or clinically inadvisable.
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

Parental approval to enroll their sick children in clinical research was studied. However, the motivation of parents to enroll healthy children and/or babies was not yet studied. The importance of clinical research among the healthy population is of extreme value. The aim of this study is to assess the motivation, medical trust and other factors influencing parents' decision to enroll their healthy baby in a clinical study.

Mothers to either healthy full-term babies post delivery or preterms will be asked to anonymously answer a questionnaire. The questionnaire includes demographic data, questions regarding their approach to medical issues, factors that influence her to enroll her baby in a research trial (different research types, different benefits from the research and fears). Finally, the mother will be asked if she will be willing to enroll her baby to on-going studies in the department.

Eligibility Criteria:
Inclusion Criteria:

* Mothers to healthy newborns during hospital stay after delivery, and mothers of preterm infants during their hospitalization in NICU.

Exclusion Criteria:

* Mothers of sick newborns (respiratory distress, receiving IV infusion, etc.) who are in the special care for newborns.
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme

About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.

The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 80
* Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
* According to MRI tumor extensions into the perirectal fat tissue (cT3)
* No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
* WHO performance status 0 - 2
* Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml)
* Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
* Adequate renal function (creatinin - not more than 1.5 mg/dl)
* Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
* Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study
* Life expectancy of at least 3 month
* Signed written Informed Consent before recruitment
* Exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

* Former radio- and/or chemotherapy
* Tumor of the upper rectum
* Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
* Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
* General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
* Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders
* Florid, serious infection at the time of recruitment
* Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance
* Evidence of lacking willingness for cooperation of the patient
* Pregnant or breast feeding women
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.

This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in this study and sign informed consent .
* Men or women aged 18-75 years
* patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
* The patients can swallow pills normally.
* ECOG score was 0 or 1.
* Have a life expectancy of at least 12 weeks.
* The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
* Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria:

* Subjects had any active autoimmune disease or history of autoimmune disease.
* Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
* Subjects with severe allergic reactions to other monoclonal antibodies.
* The subjects had a central nervous system metastases of clinical symptoms.
* A heart condition or disease that is not well controlled.
* Subjects had active infections.
* Other clinical trials of drugs were used within 4 weeks prior to the first administration.
* The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
* There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
* Age\>45 years

Exclusion Criteria:

* Disability to understand the Greek language and respond to the interview
* Fundus or corneal diseases
* Glaucoma
* Previous intraocular surgery
Online Question-answering and Conventional Consultation With a Dermatologist

Comparison of online question-answering system and conventional consultation for dermatological questions:

* same diagnosis?
* same information, which had been collected?
* same recommendations about treatment?
* what were the relevant differences of the two?

mainly, ICD codes and dermatological diagnosis codes according to the AAD will be used.

Eligibility Criteria:
Inclusion criteria:

- a conventional dermatological consultation after a question in the online question-answering system.

Exclusion criteria:

-power of veto after information of patient
Effect of Antihypertensive Drugs on Glaucoma Patients

It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. In order to explore whether antihypertensive medications would influence the neuropathy among glaucomatous population, we designed a cross-sectional observational study to analyze the retinal status among glaucoma patients with use of antihypertensive medication.

we designed a cross-sectional obeservational study to analyze the retinal status among glaucoma patients with use of hyertensive medication.

Eligibility Criteria:
Inclusion Criteria:

* age no less than 18 years

  * best corrected visual acuity better than decimal 0.3

Exclusion Criteria:

* secondary glaucoma

  * secondary hypertension
  * glaucoma-related operation history
  * pregnancy or lactation period
  * uncooperative with retinal examination
  * severe opacity with refracting media in eye
  * severe retinal diseases and neuropathy
  * congenital retinal optic nerve abnormality
  * other systemic diseases that influence hypertension and glaucoma assessment