cyrilzakka/clinical-trials huggingface dataset:
Wireless Micropump in Dry Eye Patients

The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.

The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.

Eligibility Criteria:
Inclusion Criteria:

* elimination of serious mental and psychological diseases;
* be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
* be willing to comply with the clinical trial visit schedule as directed by the investigator;
* at baseline, be within the age range of 18 to 80 years old inclusive;
* BCVA≥1.0 of both eyes for each patient;
* dry eye test is BUT\<5s and or Schimer test\<5mm/5min；
* without other ophthalmic diseases;

Exclusion Criteria:

* At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed;
* serious mental and psychological diseases;
* history of refractive surgery;
* nystagmus or failure to cooperate;
* history of intraocular surgery;
* patients with systemic diseases (such as diabetes, hypertension, heart disease, etc.)
Musculo-scrawny Manifestation Associated With the Endometriosis

The endometriosis is defined by the presence of endometriosic tissue outside of the womb and the prevalence is estimated to be 10% of women.Here is a project aimed to compare musculo-scrawny pains between patients with endometriosis and whose don't suffer of this pathology;


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 45
* consulting in Service of gynecology
* First trimester of pregnancy or for pap smears

Exclusion Criteria:

* endometriosis diagnostic already done
* rhumalogic disease known
* age \< 18 and \> 50
* menopause
Violet Light for the Suppression of Myopia

The study explores the suppression of myopia via violet light.

The study uses violet light-emitting lamps as the variable and regular, white light lamps as the control in assessing whether violet light, especially during over periods of dawn and dusk could help suppress the progression of myopia in developing children.

Eligibility Criteria:
Inclusion Criteria:

* Children must be between 5 to \<13 years old.
* Diagnosis of Myopia (ICD-10-CM Diagnosis

Code H52.13) with refractive error:

1. Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
2. Astigmatism \<=1.50D in both eyes
3. Anisometropia \<=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated.

Exclusion Criteria:

Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents

* Current or previous use of bifocals, progressive addition lenses, or multi-focal contact lenses
* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression
* Current or prior history of manifest strabismus, amblyopia, or nystagmus
* Abnormality of cornea, lens, central retina, iris, or ciliary body
* Prior eyelid, strabismus, intraocular, or refractive surgery
* Down syndrome or cerebral palsy
Scooter Board Activities in Diplegic Cerebral Palsy

Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.

Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child. A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.

Eligibility Criteria:
Inclusion Criteria:

1. CP with a diplegia
2. Age 7 to 11 years
3. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
4. They could walk with limitation or holding on according to GMFCS (level I\&II \&III) (Palisano et al., 1997).
5. They were able to understand and follow verbal instructions

Exclusion Criteria:

1. Children with any surgical interference in the upper limb.
2. intellectual disability such that simple tasks could not be understood or executed.
3. Children with any visual or auditory problems.
4. Children with any surgical interference in the lower limb.
5. Children with any structural deformities in joints and bones of lower limbs.
6. Children who suffer from other diseases or associated disorders that interfered with physical activity.
Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)

The aim of this study is to evaluate the risk factors of PNAC in neonates

Neonates with prematurity,gastrointestinal dysfunction and very low birth weights are often intolerant to oral feeding.In such infants,the provision of nutrients via parenteral nutrition (PN)becomes necessary for short term survival,as well as long-term health. Wilmore and Dudrick first reported use of parenteral nutrition(PN) for an infant more than 40years ago Soon there after physicians recognized that PN was associated with significant liver changes.In the first reported case of parenteral nutrition-associated conjugated hyperbilirubinemia (PNAC) in a premature infant hepatomegaly was noted on the18thday of fat-free PN and worsened until death on the71st day of life The hyperbilirubinemia manifest in PNAC is thought to occur from impaired hepatic bileflow, an adynamic gallbladder,and an upsurge in release of conjugated bilirubin as an infant matures.Atbirth,preterm neonates havereduced activity of the uridine diphosphate glucuronosyl transferase1A1 liver enzyme(UDPGT)that catalyzes conjugation of bilirubin As the infant develops,UDPGT becomes more functional, increasing hepatocyte efficiency for conjugation.Thus,in combination with cholestasis,and neonatal intestinal absorption of unconjugated bilirubin,more conjugated bilirubin is made available to pass from the liver into circulation. Parenteral nutrition associated cholestasis (PNAC) is the most common form of liver damage in neonates while receiving parenteral nutrition(PN).Its prevalence was reported between10%and 60%in NICU Cholestasisis acommonly described complication of PN. Its etiology is not fully understood and is thought to be multifactorial Proposed mechanisms included altered bile salt metabolisms secondary to prematurity and toxic effect of PN components on the liver the presence or absence of specific components in parenteral nutrition solutions most certainly contributing to the disease mechanism,and gastrointestinal systems .Aggravating factors such as sepsis and duration of bowel rest have also been described

Eligibility Criteria:
Inclusion Criteria:

* Neonates who received PN for ≥14 days

Exclusion Criteria::Neonates with major congenital anomaly, cholestasis at birth,diseases associated with cholestasis (i.e.,inborn errors of metabolism,viral hepatitis,cystic fibrosis and any primary cholestatic liver diseases)that were diagnosed while hospitalized.the possibility of surgical causes of conjugated hyperbilirubinemia(such as biliary atresia,choledochalcyst on abdominal ultrasonography,and hepatobiliary scintigraphy

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Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.

The Sonablate High Intensity Focused Ultrasound (HIFU) system is a non-invasive technology that uses focused ultrasound waves to ablate targeted tissue within the body without ionizing radiation or surgical excision. Through the precise delivery of ultrasonic waves, HIFU rapidly elevates the temperature in the targeted tissue, leading to the disruption of lipid membranes, denaturation of proteins, destruction of vascular endothelial cells and ultimately coagulative necrosis without damage to the overlying tissue. This device is cleared by the FDA for the ablation of prostate tissue.

This is a single arm, single institution, Phase one trial of 30 patients planned to last 18 months. The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound (HIFU) system for ablating incompetent veins of the periphery. This includes vascular malformations, varicose veins and incompetent superficial veins.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
2. Lesions no deeper than 4.0cm from the skin surface
3. Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
4. Ability to provide treatment consent for Sonablate HIFU energy delivery
5. Ability and willingness to remain compliant with recommended post-op follow-up

Exclusion Criteria:

1. Patient unable or unwilling to provide consent
2. Patient unable or unwilling to undergo HIFU energy delivery
3. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
4. Patient with known vasculitis or other inflammatory vasculopathies
5. Patients with active or prior history of DVT or PE
6. Any lesion deemed unsafe by the treating surgeon or PI of the study for HIFU at the time of treatment based on clinical assessment, ultrasonographic features and/or probe positioning limitations
7. Subject who has vascular tissue targets lying \&lt;1cm from sensitive structures or large vessels
8. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
9. Vulnerable patients
10. Subject with vessels \&gt;6 mm in diameter within the vascular tissue target
The Nitrite and Coronary Flow Study

This study is a pharmacodynamic proof of concept study investigating the physiological effects of systemic infusion of nitrite on coronary blood flow using MRI.

This is a healthy volunteer, proof of concept study.

The participant will have blood taken and this will be analysed for baseline levels of nitrate, nitrite and nitroso species. They will then have a baseline MRI to assess coronary flow in normoxia. Next, hypoxia will be induced using 12% oxygen/88% nitrogen. The participant will then have a baseline MRI to assess coronary flow in hypoxia (3 breath-hold image captures).

After all baseline images have been captured, the investigators will commence an intravenous nitrite sodium infusion, dose 70μmol, of 5 minute duration (14μmol /min-1). At the 5th minute, the participant have a further MRI image to assess coronary flow with the intervention in normoxia (3 breath-hold image captures).

A 10-minute washout will follow (with the half-life of nitrite being documented as 110 seconds). There will be optional repeat 3 breath-hold image captures at 5 minutes and at 10 minutes.

Next hypoxia will be induced using 12% oxygen/88% nitrogen again. The investigators will commence a second intravenous nitrite sodium infusion, dose 70μmol, 5 minute duration (14μmol /min-1). At the 5th minute, the participant will have a further MRI image to assess coronary flow with the intervention in hypoxia (3 breath-hold image captures).

At the end of the study the participant will have blood taken and this will be analysed for repeat levels of nitrate, nitrite and nitroso species.

All interventions will be performed by fully trained and competent medical staff.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged greater than or equal to 18 years
2. Not known to have any significant past medical history and not having regular follow up
3. Able to provide informed consent

Exclusion Criteria:

1. Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
2. Known allergy or intolerance to Nitrites
3. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency detected at screening in males of African, Asian or Mediterranean decent
4. Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH\>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
5. Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer
6. Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease
7. Any contra-indication to MRI, including the presence of an implanted metal device or suspected metal foreign bodies
Assessing the Optics of the Eye Pre- and Post-operatively in Cataract

The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract.

Cataract is the second leading cause of blindness in western Europe but the leading cause of blindness in the developing world and both central and eastern Europe. The most common cause of cataract is age. A number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. Currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. Such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. A novel instrument that offers a solution to such problems is the recently developed Binocular Optical Coherence Tomographer. Binocular-OCT is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. The Binocular-OCT has the capability to perform the functions of many clinical tools in a single instrument. Of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source OCT technology. In this study, the proposed advantages of binocular OCT system will be assessed for the management of cataract.

This research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.

Eligibility Criteria:
Inclusion Criteria:

* - Presence of cataract
* Male or female, aged 18 years or older
* Ability to understand nature/purpose of the study and to provide informed consent
* Ability to undergo binocular OCT imaging
* Ability to follow instructions and complete the study
* Ability to speak English

Exclusion Criteria:

* - Hearing impairment sufficient to interfere with hearing instructions
* Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
* Any cases where the globe has been affected by trauma, etc.
* Traumatic aetiologies of cataract
Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study


Eligibility Criteria:
Inclusion Criteria:

* A signed and dated IRB/IEC approved written informed consent form
* Male/female age 18 years (16 years where permitted) to 65 years
* Minimum body weight of 40 kg
* Patients having participated in a previous seletracetam study
* Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion Criteria:

* Ongoing psychiatric disease other than mild controlled disorders
* Subject with clinically significant abnormalities in laboratory tests or ECG
* Poor compliance with visit schedule or medication intake in a previous seletracetam study
* Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment
Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and
* Able and willing to give written informed consent.

Exclusion Criteria:

* None
Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.


Eligibility Criteria:
Inclusion Criteria:

* RA as defined by ACR/EULAR criteria
* Clinical indication to start abatacept therapy

Exclusion Criteria:

* Treatment by rituximab in the previous year
Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)

Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory hallucinations after one week of twice daily treatment with transcranial direct current stimulation (tDCS).

Background: Early onset schizophrenia (EOS) involves positives symptoms such as psychotic behaviors, as well as negative symptoms such as disruptions to normal emotions and behaviors. Antipsychotics are the primary method of treatment in pediatric populations, but can produce unpleasant or dangerous side effects. Medication response is highly variable. Recent evidence demonstrates transcranial Direct Current Stimulation (tDCS) relieving auditory hallucinations (AH) associated with schizophrenia in adults, and to a lesser degree negative and cognitive symptomology. Such studies provide important scientific and technical knowledge that may be applied to pediatric populations.

Hypothesis: 1. Primary: Youths with EOS will demonstrate amelioration of AH after administration of tDCS. 2. TDCS will be well-tolerated in pediatric populations with minimal adverse side effects.

Eligibility Criteria:
Inclusion Criteria:

* Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) primary diagnosis of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-Version IV) schizophrenia or schizoaffective disorder
* Ages 8 to 25 years-old
* Persistent auditory hallucinations
* Full Scale intelligent quotient (IQ) greater than 60.
* Stable antipsychotic medication for \> 4 weeks
* If female and not infertile patient must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment or an interuterine device (IUD).
* Legal guardian has provided written informed consent and the subject has provided written informed assent when able. Expectation that a majority of subjects will be able to assent but the potential for the younger children and/or those that are of borderline intellectual functioning will not be able to assent.

Exclusion Criteria:

* History of alcohol, substance dependence or abuse in the past 90 days
* Open skin wounds that would preclude use of TDCS electrodes
* If female, pregnancy or breast feeding, as determined during eligibility pre-screen call
* Subjects exhibiting significant ongoing severe disruptive, aggressive, self-injurious, or sexually inappropriate behavior will not be eligible for enrollment.
* Presence of any medical condition that would make treatment with tDCS less safe. This includes any implanted metal device or any cardiac pacemaker. Subjects with a history of a seizure disorder are permitted if the subject has been seizure free for 6 months and is currently treated with an anticonvulsant that has been stable for 4 weeks.
* Presence of any other condition that would make the participants unable to comply with the requirements of the study for any reason. This may include an appreciable hearing or visual impairment.