cyrilzakka/clinical-trials huggingface dataset:
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 18 years of age
* A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye

Exclusion Criteria:

* Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit
* Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included)
* Suspected allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the Investigator
* Suspected corneal ulcer
* Ocular topical steroid use within two weeks prior to baseline visit
* Ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to Baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics)
* Ocular topical povidone iodine use within 1 week prior to baseline visit
* Systemic antibiotic use within 2 weeks prior to baseline visit
* Ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit
* Ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit
* Corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any immunosuppressant use within 30 days prior to Baseline visit
* On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included)
* Known or suspected ocular fungal infection or ocular microsporidia infection
Single Versus Repeat Betamethasone in Twin Pregnancies

Thus far no robust data exist as to the effect of repeted course of antenatal corticosteroids in twin pregnancies. The investigators hypothesized that repeat course of betamethasone would further reduce neonatal morbidity in twins born before 34 weeks' gestation when compared with single dose.

Observational data suggest benefits in multiple gestations exposed to antenatal corticosteroids, although these studies have not consistently reported a statistical benefit or the benefits achieved in singletons. Nevertheless, based on the improved outcomes reported in singleton gestations, one course of antenatal corticosteroids is administered to all patients who are between 24 weeks and 34 weeks of gestation and at risk of delivery within 7 days, irrespective of the fetal number. Moreover, "a repeat course" of antenatal corticosteroids should also be considered in women who are less than 34 weeks of gestation who have an imminent risk of preterm delivery within the next 7 days, and whose prior course of antenatal corticosteroids was administered more than 14 days previously, again, irrespective of the fetal number.

The objective of the current study is to evaluate fetal outcomes in twin pregnancies following repeat betamethasone administration during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Study group - women who received 2 courses of betamethasone between 24 - 34 weeks' gestation.
* Control comparison group - women who received 1 course of betamethasone between 24 - 34 weeks' gestation.

Exclusion Criteria:

* singletone pregnancies
* higher order multiple pregnancies (triplets and above)
* known major congenital anomaly
Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery

Evaluation of the effect of peri-operative continuation of oral metformin therapy on the incidence of perioperative hyperglycemia compared to standard preoperative cessation of oral metformin therapy 24h before surgery.

Surgical procedures cause metabolic stress and can impair glucose control especially in patients with diabetes mellitus, which often results in peri-operative hyperglycemia. Peri-operative hyperglycemia is associated with impaired wound healing, secondary wound infections, endothelial dysfunction, sepsis, prolonged hospital stay and higher mortality.

Metformin is still the first line treatment in patients with type 2 diabetes mellitus.

Historically it has been stopped before surgery due to fear of hypoglycemia and metformin induced lactic acidosis. However recent studies have suggested that perioperative continuation of metformin might be safe and patients could benefit from more stable preoperative blood sugar levels.

Prospective studies evaluating the benefit of continuing oral metformin therapy in the perioperative period are rare.

The investigators plan to conduct a prospective, randomized-controlled, unblinded clinical trial where patients with type II diabetes mellitus and oral metformin therapy undergoing non-cardiac surgery will be randomized in either an interventional group or a control group. In the interventional group patients will be instructed to continue their regular metformin dose even on the day of surgery, in contrast to the control group, where the patients will be instructed to stop taking metformin 24h prior to surgery.

All other oral anti-diabetic drugs will be paused according to the local anesthesia guidelines.

The investigators plan to evaluate whether or not continuation of metformin can reduce the incidence of perioperative hyperglycemia and whether or not it is associated with elevation of blood lactate levels.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-99 years
* Diabetes Mellitus Typ 2
* Oral metformin therapy
* Non cardiac-surgery
* Informed consent

Exclusion Criteria:

* Insulin therapy
* Ambulatory surgery
* Preoperative therapy with glucocorticoids (prednisolon or equivalent ≥ 5mg/day for more than 7 days)
* Planned postoperative ICU-stay
* Advanced renal insufficiency (eGFR \< 45ml/kg/min)
* Advanced liver cirrhosis or failure (Child-Pugh B or C)
* Alcohol abuse
* Pregnancy,
* Perioperative administration of contrast dye
ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study

Taking part in recommended levels of physical activity in youth with MS may have an important and positive impact on disease symptoms, long-term disability and health outcomes. Unfortunately, youth with MS are highly inactive. In order to address this issue, the investigators have developed an MS-specific mobile application for teens called Active Teens with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the feasibility of using the ATOMIC program in youth with MS. The results of this pilot study will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth with MS.


Eligibility Criteria:
Inclusion Criteria:

1. MS diagnosis following standard definitions (IPMSSG);
2. EDSS \<4.0;
3. Ability to speak English.

Exclusion Criteria:

1. Known cardiac disease, including cyanotic congenital heart disease;
2. inability to understand instructions and tolerate proposed testing or vigorous PA.
Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial

The purpose of this study was to examine whether an app- and mentor-based program reduced anxiety among individuals reporting difficulties with anxiety.

For the intervention group, this study involved completing an 8-week program focused on helping participants reach their personality goals. The program involved app-based games, journaling, and completing behavioral challenges. Participants engaged with the study app for approximately 15 minutes per day and spoke with a study mentor weekly for 1 hour. Participants were asked to complete surveys prior to and after the program. The pre-program survey lasted approximately 1 hour, and the post-program survey lasted approximately 30 minutes.

For the control group, this study involved completing surveys. Participants were asked to complete surveys 8 weeks apart. The first batch of surveys lasted approximately 1 hour, and the follow-up surveys lasted approximately 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe anxiety levels based on the BAI and GAD-7

Exclusion Criteria:

* We excluded participants experiencing any of the following self-reported behaviors in the past 6 months: substance abuse, self-harm, harm or destruction of another person or their property, suicidal ideations, and feeling helpless after the death of a loved one
Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment

Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment

Cross-sectional quality of life survey using self-administered OPSAT-QTM questionnaire in Korean postmenopausal osteoporosis patients with bisphosphonate treatment

Eligibility Criteria:
Inclusion Criteria:

* Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation

Exclusion Criteria:

* Do not understand the contents of the questionnaire
HPV Ends Here: Increasing Uptake of the HPV Vaccine

Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

The goal of this study is to use an evidence-based approach to develop, implement and evaluate a ML intervention on increasing HPV vaccine uptake among UCDH CP patients ages 10-12.

Aim 1. Refine and finalize a parent, primary care team and clinic ML intervention to increase uptake and completion of the HPV vaccine series among adolescent patients of the UCDH CP practices. In Phase 1, semi-structured qualitative interviews with key stakeholders will be conducted to refine the content and implementation approaches.

Aim 2. Conduct and evaluate the effectiveness and sustainability of the ML intervention. In Phase 2, twelve UCDH CP practices will be recruited to participate in a 2-arm parallel group randomized controlled trial. The primary outcome age-appropriate completion of the HPV vaccine series will be assessed via Epic, the UCDHS electronic medical record (EMR) software. It is hypothesized that patients of clinics in the intervention condition will have significantly higher HPV completion rates compared to patients of clinics in the control condition (usual care).

Eligibility Criteria:
Inclusion Criteria:

• Clinic patients between the ages of 10-12 who are eligible for the HPV vaccine

Exclusion Criteria:

• Clinic patients who already received the HPV vaccine or with any contraindication to the HPV vaccine.
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
* Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
* Patient who fulfils MRI solutions conditions
* Patient who provides signed and dated informed consent

Exclusion Criteria:

* Implanted or planned to be implanted non MR-compatible device or material
* Permanent Atrial Fibrillation (for DR devices)
* Diaphragmatic/phrenic stimulation
* Claustrophobia
* Incessant ventricular tachyarrhythmia
* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical trial that could affect the results of this study
* Patient is minor (less than 18-years old)
* Patient is pregnant - Patient is forfeiture of freedom or under guardianship
Cerebral Antibiotics Distribution After Acute Brain Injury

The aim of the study is to explore the distribution of antibiotics in the brain after an acute brain injury because brain infections treatment is still an health care problem.


Eligibility Criteria:
Inclusion Criteria:

* Acute brain injury
* Patient who receive an antibiotic for an infection or prophylaxy
* Glasgow coma score \< 8

Exclusion Criteria:

* Age \< 18 years old
* Pregnant woman
* HCV, HIV, HBV infection
Blood Pressure in Adolescents With PReclampsia and Eclampsia.

Levels of blood pressure in adolescents with preeclampsia and eclampsia:

Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia.

The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg.

The sample is 1050: (350 Cases and 700 Controls).

Levels of blood pressure in adolescents with preeclampsia and eclampsia: cases and controls study.

It is unknown whether the blood pressure levels used for the diagnosis of preeclampsia have the same impact in adolescents as in older women, however for the diagnosis of preeclampsia and severe hypertension the same criteria of hypertension are used regardless of age maternal.

It is necessary to do research to determine the values of blood pressure with which adolescents convulse and also to validate if slight increases in baseline blood pressure in adolescents are associated with prediction of preeclampsia and eclampsia.

Unfortunately, 85% of teenage pregnancies occur in non-industrialized countries such as those in Latin America, and it is estimated that 25% of maternal deaths occur in adolescents

Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. Controls are patients with the same criteria but WITHOUT hypertension during this pregnancy.

The statistical analyzes are based on comparing blood pressure levels between the two groups, in addition blood pressure levels like 30/15 on the systolic and diastolic basal levels will be created and compared between the two groups, especially when it is not possible to have 140 / 90 mm Hg.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for inclusion cases: Patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of age. pregnancy. That you get the data of the termination of your pregnancy.

Exclusion Criteria:

* Patients with pregnancy that starts before 19 years of age that does NOT develop preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of pregnancy. That you get the data of the termination of your pregnancy.
Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye

This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be diagnosed with clinically significant dry eye.
* Subjects have no active ocular disease or allergic conjunctivitis.
* Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
* Subjects must be willing and able to follow instructions.
* Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
* Subjects must meet plasma donor criteria as established by University of Rochester Transfusion Medicine \& Blood Bank.

Exclusion Criteria:

* Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
* Is currently on a course of antibiotics
* Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
* Is considered by the University of Rochester Transfusion Medicine \& Blood Bank not a suitable candidate for blood donation.
Herbal Medication (Gongjin-dan) for Chronic Dizziness

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial to explore the effectiveness of an herbal medication, Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis, the participants will be followed up to 12 months from randomization.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 79 years, of either sex
2. Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
3. Recurring symptom of dizziness for more than 1 month
4. Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline
5. Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
6. Willingness to provide written informed consent

Exclusion Criteria:

1. Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)
2. Dizziness attributable to central nervous system (CNS) disorders (e.g., cerebellar ataxia, stroke, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines, and others)
3. Cervicogenic dizziness
4. Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others)
5. Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others)
6. Dizziness attributable to medication side effects
7. Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
8. Intake of other antivertiginous drugs that cannot be discontinued
9. Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness
10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine \> 3 × upper limit of normal range at baseline
11. Women of (suspected) pregnancy or breast-feeding
12. Allergic reactions to the study medications
13. Suspicion of alcohol and/or drug abuse
14. Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications
15. Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions
16. Other reason for ineligibility of participation
Body Composition in Children With Inflammatory Bowel Disease

Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Evidence regarding the effect of different therapeutic approaches on body composition in children with IBD is scarce and inconsistent. Furthermore, most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for body composition assessment, while information on the usefulness of air displacement plethysmography (ADP) for this assessment is lacking.

Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and at various intervals during follow up.

Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider Children's Hospital.

Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative colitis (UC).

Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and lean mass at diagnosis and during treatment.

Secondary outcome measures: Correlation of body composition to skin fold, mid arm circumference measurements, BMI, inflammatory markers, gender, disease activity and physical activity.

Children diagnosed with either Crohn's disease (CD) or Ulcerative Colitis (UC) under follow-up at the Pediatric gastroenterology institute, Schneider Children's Hospital, will be enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment all patients will perform body composition assessment by air displacement plethysmography (ADP) and DEXA (no greater than 7 days between the 2 methods of measurement). At one and two years following initial assessment ADP measurement will be repeated, mid arm circumference and skin fold measurements will be taken and the patient will fill a physical activity questionnaire. Disease activity score (either Pediatric Crohn's Disease Activity Index for CD or Pediatric Ulcerative Colitis Activity Index for UC) will be calculated. Similar evaluation will be performed prior and immediately following exclusive enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBD
* Age: 6 - 17 years ( inclusive)
* Informed consent

Exclusion Criteria:

* Pregnancy
* Non IBD associated chronic diseases
* Morbid obesity