cyrilzakka/clinical-trials huggingface dataset:
Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery

This study aims to evaluate the efficacy, safety, and potential mechanisms of prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts.

Researchers will compare prednisolone acetate eye drops to sodium hyaluronate eye drops to see if prednisolone acetate eye drops work to relieve intraoperative and postoperative pain during second-eye cataract surgery.

Participants will:

1. Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery
2. Finish cataract surgery and routine postoperative follow-up
3. Pain questionnaire completed after cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Age between 50-80 years old;
* A clear diagnosis of age-related cataract, having completed the first eye cataract surgery at our hospital, and planning to have the second eye cataract surgery with the same doctor;
* The interval between the two surgeries is ≤30 days;
* Capable of cooperating to complete iris optical coherence tomography angiography examination;
* Based on our team\&#39;s previous research, a predictive scoring formula for pain during the second eye surgery has been derived (Predicted score = 1.36 + 4.93 \* preoperative iris vessel area density - 0.24 \* surgical interval (weeks)), and the calculated predicted score is \&gt;2.

Exclusion Criteria:

* History of ocular trauma, ocular surgery, uveitis, fundus disease, glaucoma, or recent history of episcleritis, keratitis, severe dry eye, and other ocular surface disease episodes;
* Participation in intraocular or systemic medication clinical trials within the past 6 months;
* Having an autoimmune disease or currently undergoing immunosuppressive therapy;
* Having a psychiatric disorder such as anxiety or depression;
* History of using glucocorticoid eye drops for treatment in the second eye within the past month;
* Long-term use of drugs that can cause intraoperative floppy iris syndrome, such as alpha-blockers;
* Severe complications occurred during or after the first eye surgery (e.g., posterior capsule rupture, zonular exercise, nuclear drop into the vitreous cavity, postoperative endophthalmitis, glaucoma, etc.).
Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants

Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* \<32 gestational weeks preterm infants

Exclusion Criteria:

* Major congenital anomaly
* Small for gestation age
* Grade III-IV intracranial hemorrhage
Biosignals by Wearable Devices in Hypothyroidism

This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

A prospective observational cohort study including two groups.

Hypothyroid group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Control group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period.

Association between thyroid status and bio signals will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with differentiated thyroid carcinoma underwent total thyroidectomy
* Patients who are planned to get radioactive iodine therapy
* Patients who are able to use wearable device and smartphones

Exclusion Criteria:

* Patients who are not able to use wearable device and smartphones
* Patients who are maintaining drugs affecting heart rate
* Patients who have any other disease which can affect biosignals
Impact of Fever Prevention in Brain Injured Patients

This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.

Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
3. Meets disease-specific criteria

Exclusion Criteria:

1. Fever (≥38°C) prior to study enrollment
2. Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome
3. Has a pre-morbid condition with poor likelihood of survival to 6 months
4. Has a pre-morbid mRS ≥3
5. Diagnosed with brain death
6. Is undergoing therapeutic hypothermia therapy
7. Has sustained neurological injury felt to be catastrophic with little chance of recovery
8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash)
9. Has poor skin integrity or poor tissue perfusion
10. Participation in a concurrent investigational / interventional study (medical device or drug)
Effect of Weight Loss Diet and Pumpkin Seed Flour Consumption on Obese Women

This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.


Eligibility Criteria:
Inclusion Criteria:

* age from 20 to 59 years old.
* body mass index above 30 kg/m2

Exclusion Criteria:

* diabetic
* loss weight before the research
* consumption of vitamins or dietary supplement.
* pregnancy
Use of Fresh Platelet Rich Plasma With Concentrated Leukocytes or Fresh Platelet Rich Plasma Without Concentrated Leukocytes in the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial

The aim of the study is to compare the triple infiltration of Fresh Platelet Rich Plasma with concentrated Leukocytes against triple infiltration of Fresh Platelet Rich Plasma Without Concentrated Leukocytes in the treatment of Knee Cartilage Degeneration in a Double Blind Randomized Controlled Trial

Platelet Rich Plasma has a consolidated use in the field of orthopedic surgery to reduce inflammation, promoting bone regeneration and healing of surgical wounds.

Some clinical studies demonstrated the utility of the intra-articular infiltration of Platelet Rich Plasma in the treatment of knee articular cartilage lesions, becoming a common conservative strategies in the management of these diseases.

Actually, there are some different kinds of PRP formulations, in particular, the scientific debate is focusing on the role of Leukocytes and if it is better using fresh or frozen PRP.

At the moment don't exist randomized controlled clinical studies comparing fresh PRP rich in Leukocyte against PRP poor in Leukocyte in the treatment of knee cartilage lesions.

The study has two groups of patients, the first will undergo to three infiltrations of Fresh Platelet Rich Plasma With Concentrated Leukocytes and the second will undergo to three infiltrations of Fresh Platelet Rich Plasma Without Concentrated Leukocytes, each infiltrations will be done weekly.

Eligibility Criteria:
Inclusion Criteria:

Patients with degenerative pathology of the knee cartilage with:

1. Age between 18 and 75 years;
2. Unilateral involvement;
3. Signs and symptoms of degenerative pathology of the cartilage of the knee;
4. Radiographic or MRI signs of degenerative pathology of the cartilage of the knee (Kellgren-Lawrence 1-4 degrees);
5. Hemoglobin\> 11 g / dl; Platelet count\> 150,000 plt / mm3 (recently performed blood count);
6. No clinically significant electrocardiographic alteration (recently performed ECG).
7. Patients' ability and consent to actively participate in clinical follow-up;
8. Signature of informed consent.

Exclusion Criteria:

1. Patients undergone to intra-articular infiltration of another substance in the previous 6 months;
2. Patients undergone knee surgery in the previous 12 months;
3. Patients with malignant neoplasms;
4. Patients suffering from rheumatic diseases;
5. Patients suffering from diabetes;
6. Patients with hematologic diseases (coagulopathies);
7. Patients on anti-anticoagulant therapy;
8. Patients suffering from thyroid metabolic disorders;
9. Patients abusing alcoholic beverages, drugs or drugs;
10. Body Mass Index\> 35;
11. Patients who have taken NSAIDs within 3 days before taking blood;
12. Patients with cardiovascular diseases for which the 150 ml blood test would be contraindicated;
13. Patients with a recently performed blood count with Hb values \<11 g / dl and Platelets \<150,000 plt / mm3.
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.

The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks.

One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.

For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group.

Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.

Eligibility Criteria:
Inclusion Criteria

1. Adult subjects aged 18-70, that are in good health.
2. Subject must have:

   2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).

   2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.
3. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
4. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.

Exclusion Criteria

1. Current or history of oral cavity cancer or oropharyngeal cancer.
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing by subject report.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
6. Subjects that do not brush regularly.
7. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
Cooling to Optimize Organ Life in Donor Study

The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years;pronounced dead as per hospital brain-death criteria
* Accepted by organ procurement organization for organ donation
* Subjects within 3 hours of brain death pronouncement

Exclusion Criteria:

* Consent cannot be obtained from authorized representative;mean arterial pressure \< 60 mmHg and/ or more than 2 vasopressor and/or inotrope use
* Presence of 2nd or 3rd degree heart block
* Ongoing extracranial hemorrhage
* International normalized ratio \> 3.0
* Donors with human-immunodeficiency virus infection
* Pregnancy
Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
2. Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1 segment of the middle cerebral artery.
3. DWI shows an infarct volume less than one-third of the MCA territory, with onset of symptoms ≤6 hours, or a head CT within 24 hours of onset indicating an ASPECT score ≥6.
4. Symptom onset time is ≤6 hours or between 6-24 hours with multimodal imaging (assessment) confirming eligibility for thrombectomy.
5. Pre-stroke mRS score is ≤1.
6. NIHSS score before thrombectomy is between 6 and 25.
7. With vascular recanalization of mTICI \> 2b/3.

6. Informed consent form signed.

Exclusion Criteria:

1. Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
2. Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
3. Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
4. Head CT/MRI suggests acute cerebral infarction in both sides;
5. Patients with a history of congenital or acquired bleeding disorders, coagulation factor deficiencies, or thrombocytopenia;
6. Patients with blood pressure more than 180/110 mmHg after antihypertensive treatment;
7. Patients who are pregnant or breastfeeding;
8. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;

6. Patients with other severe diseases resulting in an expected survival of less than 90 days; 7. Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition; 8. Patients who cannot cooperate with informed consent.
Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries

The primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)

This is an observational cohort study utilising all available data from the Tysabri TOUCH (TYSABRI Outreach: Unified Commitment to Health) prescribing programme (US) supplemented with data from European Union (EU) multiple sclerosis (MS) registries to estimate the risk of PML and other serious opportunistic infections (OIs) among patients on Tysabri who have switched from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate).

This study will provide cumulative data from its two components: a retrospective component (data captured prior to 01 January 2016) and a prospective component (data captured, and patients followed up, from 01 January 2016 through 31 December 2023; total prospective study duration of 8 years). All patients who switched to Tysabri from another DMT through 31 December 2020 will be included. The study will continue to follow-up patients until 31 December 2023 to allow for a minimal follow-up of 3 years.

Eligibility Criteria:
Key Inclusion Criteria:

* All TOUCH and available EU MS registry participants who have switched from DMTs (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of Tysabri.

Key Exclusion Criteria:

* Not applicable

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis

The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (\>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.


Eligibility Criteria:
Inclusion Criteria:

* HCV RNA in serum
* AST/ALT greater than the upper limit of normal range
* HVPG \>5 mm Hg
* Non-response or contraindication to a standard course of antiviral therapy

Exclusion Criteria:

* Active alcoholism
* HIV infection
* Serum creatinine \>1.2 mg/dl, hemoglobin \<11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease
* Decompensated chronic liver disease
* Pregnancy
* Hypersensitivity to the drugs of the study
* Severe concomitant disease
The Impact of Bundled Payments on Quality and Cost of Care

Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. This study will use Medicare claims data to evaluate the effect of participation in a large Medicare bundled payment program on the quality and costs of care for common medical and surgical conditions.

The overall objective is to examine the effects of the Bundled Payments for Care Improvement (BPCI) Model 2 on the quality and costs of care for conditions related to seven of the ten Medicare severity disease-related groups (MS-DRGs) most commonly selected by program participation. Five of these are surgical (major joint replacement of the lower extremity; double joint replacement of the lower extremity; revision of the hip or knee, hip and femur procedures except major joint; lower extremity and humerus procedure except hip, foot, and femur) and two are medical (simple pneumonia and respiratory infections; chronic obstructive pulmonary disease, bronchitis/asthma). These MS-DRGs represent two larger service lines: orthopedics and pulmonary. For each of these seven MS-DRGs, the team will first describe characteristics of provider organizations participating in bundled payment arrangements, including geographic characteristics and clinical volume. We will subsequently empirically test the effect of bundled payment arrangements on quality outcomes and costs of care for these conditions. Additionally, the team will examine any spillover effects that occur within the service lines that contain these seven MS-DRGs.

Eligibility Criteria:
Inclusion Criteria:

* Provider organizations that participate in model 2 of the BPCI program, accept bundled payment for the ten most common MS-DRGs, and have at least ten or greater episodes in each of the MS-DRGs.

Exclusion Criteria:

* Provider organizations who participated in the BPCI program, but do not meet inclusion criteria will be excluded.
Antiphospholipid Antibodies and Fetal Growth Restriction

The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24-34 weeks.
* Ultrasonographic evidence of fetal growth restriction

  * Abdominal circumference \< 3rd percentile.
  * Doppler with increase of placental resistance.

Exclusion Criteria:

* Known antiphospholipid syndrome.
* Known presence of antiphospholipid antibodies.
* Patients with systemic lupus erythematosus.