cyrilzakka/clinical-trials huggingface dataset:
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

In this prospective randomized controlled double blind pilot clinical study, we aim to assess whether administration of a topical corticosteroid would attenuate epiretinal membrane formation following development of retinal tears treated with laser retionpexy.

Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% - 28.9% of eyes in persons aged 40 years or older. \[1\] While often idiopathic in nature, ERM formation has been associated with retinal tears, possibly due to a breakdown of the blood-retinal barrier \[1-3\]. Pathological analysis of ERM content shows inflammatory mediators such as cytokines, growth factors and interleukins, which can promote fibroblast remodelling that leads to a contractile scar formation on the retinal surface. \[1, 4-8\] For this reason, ERM formation has been suggested to be an aberrant tissue repair or wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid following retinal tears should theoretically reduce the risk of ERM formation. \[9-10\] In this study, we aim to assess whether administration of a topical corticosteroid would attenuate ERM formation following laser retinopexy of retinal tears.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18 to 80 (inclusive)
* English-speaking
* Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)

Exclusion Criteria:

* Patient refusal or delay of retinopexy procedure for more than 48 hours after diagnosis
* Patients who are pseudophakic or aphakic
* Medical conditions contraindicated with prednisolone: viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fundal diseases of ocular structures; mycobacterial infections; hypercortisolism.
* Previous history of epiretinal membrane, retinal surgery (cryo or laser)
* Patients with hypersensitivity or contraindication for corticosteroids (viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fungal diseases of ocular structures; mycobacterial infections; hypercortisolism).
Drug-Related Problems in Neonatal Patients

Drug-related problems in newborn babies have been reported with a rate of 4-30%. It is estimated that the higher rates of these problems in hospitalized children under the age of two are related to the variety of drugs used and the differences in the age, weight and diagnosis of the patients. In this context, with the clinical parameters and demographic data obtained in the first 24 hours of the patients hospitalized in the neonatal intensive care unit, machine learning algorithms are used to predict the risks that may arise from possible drug-related problems (prescribing and administration errors, side effects and drug-drug interactions) that may occur during hospitalization. The algorithm, which will be created by modeling with a high number of big data pool, is planned to be transformed into a clinical decision support system software that can be used easily in clinical practice with online and mobile applications. By processing the data of the patients to be included in the model, it is aimed to prevent and manage drug-related problems before they occur, as well as to provide cost-effective medşcation treatment to patients hospitalized in the neonatal intensive care unit, together with a reduction in the risk of drug-related mortality and morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Newborns aged 0-28 days,
* Consent form taken by the parents to participate in the study,
* Patients admitted to neonatal intensive care unit or surgical wards

Exclusion Criteria:

* Have a postnatal age greater than 28 days,
* Patients who will not be given any medication,
* Patients who took part in any drug research within the last 28 days
Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users

To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.

A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible subjects must be 18 years of age or older
2. Eligible subjects must be willing and able to provide an English language written Informed Consent Form
3. Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
4. Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
5. Have new contact lens to wear starting the first day after iLux treatment
6. Have an OSDI score greater than ≥ 12
7. Have a CLDEQ8 score ≥ 12
8. Have a minimum meibomian gland expression score ≤ 12 (using MGD scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-45.
9. Be able and willing to follow instructions and participate in all trial assessments and visits
10. Eligible subjects must be fully vaccinated against COVID-19

Exclusion Criteria:

1. Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
2. Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
3. Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
4. Be a woman who is pregnant, nursing, or planning a pregnancy
5. Had ocular surgery within the last 90 days
6. Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1
7. Had Intense Pulsed Light (IPL) treatment within last 30 days
8. Have active ocular infection or inflammation
9. Be a current wearer of extended wear contact lenses
Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

Eligibility Criteria:
Inclusion Criteria:

* presence of an edentulous atrophic zone in the posterior segment of the maxilla
* height of the sinus floor ≤4 mm
* desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants;
* ≥ 21 years of age
* good general health
* no contraindication for oral surgical procedures
* not being pregnant

Exclusion Criteria:

* present a systemic disordered
* had a chemotherapic or radiotherapeutic treatment
* are smokers \>10 cigarettes per day
* have an acute or a chronic sinusitis
* had a previous bone augmentation procedures in the zone of interest.
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.

This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who provided written informed consent.
* Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
* Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
* Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
* Subjects with normal ECG, chest X-ray (PA view) and vital signs.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti

The purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

This study is investigating the effect of exercise therapy and/or abdominal binding on inter-rectus distance, abdominal muscle strength and endurance, lumbopelvic dysfunction, urogynecological complaints, perceived function, and body image in post-partum women with diastasis recti

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years old
* given birth to their first child, vaginally, in the last three to four weeks
* inter-rectus distance of two finger widths of greater on palpation during head lift

Exclusion Criteria:

* history of persistent pain with intercourse prior to pregnancy
* diagnosed with neurological impairments affecting the central nervous system or sacral nerves
* diagnosed with connective tissue disorders
Availability Study of ACTH to Treat Children SRNS/SDNS

Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Eligibility Criteria:
Inclusion Criteria:

1. age:3-12 years old
2. primary nephrotic syndrome
3. SRNS or SDNS
4. Minor lesion or minimal change disease
5. Signed informed consent

Exclusion Criteria:

1. Second nephrotic syndrome
2. allergic to ACTH
3. Refuse to signed informed consent
4. have had ACTH treatment
5. serious complication
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.

Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive "standard care" without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, \& 12 months, for symptom levels and overall quality of life during the twelve-month study period.

Eligibility Criteria:
Inclusion Criteria:

18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent \& consent to use the Cancer Symptom Monitor -

Exclusion Criteria:

Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Surgical Intervention and Lymphatic Diseases.

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Lymphatic-related diseases such as lymphedema often result from damage to the lymphatic system due to tumor removal and lymph node dissection surgeries, as well as tissue fibrosis caused by post-operative radiation therapy. This can lead to obstruction in the proximal channels of lymphatic flow, resulting in swelling, deformity of the distal limbs, poor wound healing, or cellulitis.

In the case of lymphatic-related diseases like lymphedema, improvement can be achieved through surgical interventions. Surgery can be categorized into physiologic reconstruction and volume reduction procedures. Among them, Supermicrosurgical Lymphaticovenous Anastomosis (LVA) is a form of physiologic reconstruction. LVA involves the separation of lymphatic vessels in the affected limb and their anastomosis with nearby small veins to alleviate limb swelling and reduce the risk of cellulitis. When using lymphaticovenous bypass surgery to treat lymphedema, the ideal scenario is to use veins for anastomosis that do not have venous blood reflux. This is because veins generally have higher blood pressure than lymphatic fluid, and if venous blood flows into the lymphatic vessels over the long term, it can reduce the patency of the lymphaticovenous anastomosis site. The choice of anastomosis technique, based on the size and position of the lymphatic vessels and veins, can also impact the post-operative outcomes. Therefore, factors such as lymphatic vessel size, flow rate, function, vein size, pressure, and the presence of reflux are closely related to the success of lymphaticovenous bypass surgery.

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Eligibility Criteria:
Inclusion Criteria:

* This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 1, 2015, to August 31, 2022.

Exclusion Criteria:

* Patients under the age of 20.
* Patients with incomplete medical records.
Novel Drug Delivery Technique Via Retroject Device

The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) \>20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.


Eligibility Criteria:
Inclusion Criteria:

* age 55 years or older of both sexes
* IOP \>20 mmHg on maximal treatment
* \<20/200 visual acuity
* willing to sign informed consent forms

Exclusion Criteria:

* monocular patients with bleeding disorders
* patients on anticoagulant or antiplatelet medications
* patients who had prior laser surgeries (SLT or ALT)
Comparison of Pesticide and Pharmaceutical Contaminants Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women

Aim: In this study, pesticide and pharmaceutical contaminants levels in the placenta and cord blood of pregnant women with fetal growth retardation and healthy pregnant women will be compared in placenta and cord blood samples after delivery.

The study will be conducted with a total of 40 pregnant women, 20 of whom are in the control groups and those with FGR diagnoses. Cases in both groups will be matched in terms of demographic information. Demographic information (including socioeconomic status, educational level, region of residence), ultrasound and Doppler examination results, newborn weight at birth, APGAR score, gender, mode of delivery, whether there is a need for neonatal intensive care or not will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-40 years
* Gestational age between 320/7 - 396/7 weeks
* Singleton pregnancy
* For the FGR group: estimated fetal weight \<10th percentile
* For the control group: being healthy pregnant
* Intact amniotic membrane

Exclusion Criteria:

* Multiple pregnancies
* Cardiovascular disease
* Chronic hypertension
* Autoimmune disease
* Intrahepatic cholestasis of pregnancy
* Preeclampsia-eclampsia
* Sepsis
* Placenta accreta spectrum
* Abnormalities of placenta
* The chromosomal or congenital structural anomaly of the fetus
* Smoking
* BMI \>30 kg/m2
Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures

This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.

This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.

Primary objective The overall objective of the study is to compare the 1-year patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS5) after standard tension band fixation with locking plat fixation for patients with patella fractures.

Secondary objectives Several other analyses are of interest and are planned but are not objectives of this study. Therefore, these analyses will, for the major part, hypothesis-generating. Analyses of this type include, but are not limited to harms, muscle atrophy, pain, general health, gait function, time to return to work and economical consequences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Patella fracture suitable for surgically treatment, with both surgical methods
* AO classification 34-B, 34-C

Exclusion Criteria:

* Open patella fracture above Gustillo grade 2
* Bilateral patella fracture
* Total knee replacement in the affected extremity
* Other fractures of the affected extremity within the previous 12 months.
* Other reasons for exclusion (unable to understand Danish, mentally unable to participate, etc).
* Prior ipsilateral patella fracture
EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

Diabetes represents a substantial burden on health care systems. People with prediabetes IGT (impaired glucose tolerance) or IFG (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years.

OBJECTIVE: To evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients.

MATERIAL AND METHODOLOGY: Randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). Study population: obese or overweight patients of the OSI Araba aged 35-70 years who are in the contemplation stage.

Response assessment: Primary variable: glycosylated hemoglobin; Secondary variables: Body Mass Index (BMI) (kg/cm2); blood pressure (mm Hg); satisfaction questionnaire score; physical exercise index (IPAQ) (METs). Statistical analysis: The analysis of the main variable (change in HbA1c at 6 months between both groups) will be assessed by analysis of covariance, ANCOVA, adjusting for baseline HbA1c. Sample size: 41 patients per arm (+30% to cover losses to follow-up).


Eligibility Criteria:
Inclusion Criteria:

Prediabetics with glycosylated hemoglobin (HbA1c) 5.7-6.4 (24, 38) and signing informed consent.

-

Exclusion Criteria:

Presence of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus.

of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus.