cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use

Several recent clinical trials have highlighted the potential role of Product in promoting eye health.product whose structural and functional characteristics make it a promising bioactive compound in the prevention of several human diseases as well as in the maintenance of a good health status. it might relieve eyestrain in people using computer monitors as suggested who conducted a double-blind randomized clinical trial by enrolling visual display terminal workers and prescribed them product or placebo. Study outcomes were objectively evaluated by using a proper instrumentation to measure eye muscle endurance. Subjects receiving Product experienced a significant relief from eyestrain compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Girls and Boys between the ages 10 to 14.
2. Participants who have a history of using a digital device (phone, tablet, computer, etc) at least 4 hours per day, for minimum of last 3 months prior to screening.
3. Participants who have complained of eye strain on use of digital device.
4. Participant with CVS-Q score ≥ 8.
5. Participants who have history of playing video game for least 6 hours per week.
6. Best Corrected Visual Acuity (BCVA) of 20/20.
7. Participants with ≤ 12.5 cm and ≥ 6 cm amplitude on accommodation test.
8. Participants with parents who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
9. Participants with parents who are able to give written informed consent and willingness to participate in the study and comply with its procedures

Exclusion Criteria:

1. Participant with CVS-Q score ≥ 19.
2. Asthenopia Visual Fatigue Likert Scale Score ≤ 2 for each symptom.
3. Near Point Convergence (NPC) no further than 10 cm
4. Stereopsis of ≥ 40 arc/sec
5. Not diagnosed with amblyopia
6. Refractive error less than -3 or more than +2
7. Participants who wear contact lenses.
8. Participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues.
9. Participants with a history of eye alignment or binocularity issues.
10. Participants who are color-blind.
11. Participant on any antioxidant, retinols and carotenoid supplements.
12. Participants who have used eye care products within 3 months prior to the screening visit.
13. Participants who have been diagnosed with Type I diabetes.
14. Participants who have been diagnosed with Covid-19 one month before the screening visit.
15. Participants scheduled to receive any vaccination during the study period.
16. Participants who have immunosuppressive disorders or are taking immunosuppressive medication.
Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers.

The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects


Eligibility Criteria:
Inclusion Criteria:

I. Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups

1. Subjects with an existing diabetic foot ulcer
2. Subjects determined "at risk" for an ulcer

Exclusion Criteria:

1. History of heart failure
2. Rheumatoid arthritis
3. Pregnant or lactating women
Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
* Female subjects agree to use highly effective contraception or be of non-childbearing potential.
* Written informed consent must be obtained before any assessment is performed.
* Able to communicate well with the Investigator/designee.

Exclusion Criteria:

* Any known reaction to study drug or components
* concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
* No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
* Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
* Excessive use of caffeine-containing beverages
* Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
* Presence or history of drug of alcohol abuse.
* Positive screen for drugs-of-abuse or cotinine.
* Blood donation in excess of 500mL within 3 months.
* Participation in another clinical study with licensed or unlicensed study drug within 3 months of first IMP administration.
* Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
* Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine (including COVID-19 vaccine) 14 days before dosing with study drug until telephone follow-up.
Analgesic Effect Between TAP Block and Continuous Wound Infusion in Abdominoplasty Surgery

The purpose of this randomized controlled study is to compare the postoperative analgesic effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction. Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of local anesthetics and clonidine are used.

In a first group, patients receive, after induction of anaesthesia and before surgery, a TAP block (transverse abdominal plan block) with 3mg/kg Ropivacaine 0.5% (maximum 200 mg) and 150 microg Clonidine.

In a second group, before skin closure, a multiholes catheter was inserted beyond the skin. 20 mg Ropivacaine 0.2% added with 150 microg Clonidine was injected as bolus dose through this catheter followed by a continuous infusion of Ropivacaine 0.2% 10ml per hour during the following 9 hours (total dose of 200 mgr).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for abdominoplasty combined with flank liposuction

Exclusion Criteria:

* Allergy to local anesthetics or clonidine
* Coagulation disorders
* History of chronic pain
* Alcohol or drugs dependance
* Refusal of the patients
Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 85 years (inclusively).
2. Willing and able to provide informed consent.
3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
4. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
5. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.
6. Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):

   * Use of external nasal dilator strips (eg, Breathe Right Strips)
   * Use of internal nasal dilator cones
   * Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
   * Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)
7. Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.

Exclusion Criteria:

1. Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
2. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
3. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
4. Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
5. Known or suspected to be pregnant or is lactating.
6. Participating in another clinical research study.
7. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.

For Group A, after screening, eligible participants will be treated from day 1 and followed up for 24 months. The purpose of Group A was to confirm investigator's use of correct injection technique.

For Group B, the study includes two phases as follows:

Main study phase: It is randomized, evaluator-blinded and no-treatment controlled. After screening, all eligible participants will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the participants will be followed up for 12 months.

Extension study phase: After the main study phase, the Treatment Group will be followed up for additional 12 months.

Each subject assigned to Group A and Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals.

Participants assigned to the Control Group will not receive treatment during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent to participate in the study.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Participants seeking augmentation therapy for the midface.
4. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any of the constituents of the product.
2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
3. History of severe or multiple allergies, such as anaphylaxis.
4. Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the area to be treated within 6 months before treatment.
5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
6. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant in the area to be treated.
7. Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. participants not likely to avoid other facial cosmetic treatments, participants anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.


Eligibility Criteria:
Disease Characteristics:

* Patients with a documented histologic or cytologic diagnosis of B-cell NHL.
* Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority.
* Patients with at least one measurable tumor site \> 1.5 cm in at least one dimension.

Prior/Concurrent Therapy:

* Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
* Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA).
* Radiotherapy: No prior radiation therapy to \>25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible.

Patient Characteristics/Inclusion Criteria:

* Age Range: Male or Female at least 18 years of age
* Performance Status: Patients with a Karnofsky performance status \> 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks.
* Hematopoietic: Hemoglobin \> 10 g/dL; ANC \> 1.5x10\^9/L; Platelets \> 100x10\^9/L;
* Hepatic: Serum bilirubin \< 2.0 mg/dL; AST and ALT \< 2 x ULN w/o liver metastases or \<5 x ULN w/liver metastases
* Renal: Creatinine \< 2.0 mg/dL
* Cardiovascular: Patients with LVEF \>/= 50% by MUGA or 2D-ECHO.
* Pulmonary: Patients with DFCO and FEV1 \>/= 60% by required Pulmonary Function Tests.
* Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Effects of Plyometric Training Versus Bowling Drills on Fast Bowlers

The sport of cricket calls for a high level of physical fitness and mastery of skills. Cricket players, especially fast bowlers, must have the skills to maintain consistency in their pace and accuracy while bowling helps them prevent batsmen from settling into their innings and helps bowlers succeed in getting wickets. Fast bowlers, being some of the most influential players on the cricket field, must undergo specific trainings. Sports-specific Drills and Plyometric training are two important types of training that help athletes in their particular sports.

Randomized Clinical Trial (RCT) will be conducted to compare the effect of plyometric trainings versus bowling drills on speed and agility among fast bowlers. A sample size of 22 club level fast bowlers will be taken through Non-Probability Convenience Sampling Technique. One group of 11 participants will perform Plyometric training and other group of 11 participants will perform Bowling Drills and Ladder drill. Both groups will perform their respective trainings for 6 weeks with 3 sessions per week. Before and after completion of the respective training, speed, agility will be assessed through 30m sprint test, run-a-three test, illinois test, t-test respectively and bowling speed will be measured using a stopwatch to calculate the time required for the ball to reach a batsman and within 22 yards of the pitch. Data will be analyzed by using SPSS for windows version 25.

Eligibility Criteria:
Inclusion Criteria:

* Only male fast bowler will be recruited to the study.
* Athletes must have been practicing fast bowling for at least one year at the club level.
* Athletes must have been between the ages of 20-35.

Exclusion Criteria:

* Athletes who will have any systemic disease which can hinder the trainings.
* Athletes who would not commit to full participation in the study's training regimes.
* Athletes who have received surgery in the three years prior to the study or undergone rehabilitation within the past year.
* Athletes currently engaged in plyometric training as this may confound the study
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients.

Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.

Eligibility Criteria:
Inclusion Criteria:

* ages less than 18 years .
* Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
* Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
* Vitamin D deficient or insufficient CF and non CF bronchiectasis patients

Exclusion Criteria: if they had

* sufficient Vitamin D level .
* chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
* reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.
Biomarkers in Thoracic Aorta Surgery

Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.

This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

* Hemolysis in blood sample
Special Survey for Type 1 or Type 2 Diabetic Patients

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes requiring insulin therapy

Exclusion Criteria:

* Patients who had not been treated more than 3 months at the same investigational site
* Patients who had treatment history of NovoRapid® (insulin aspart)
Evaluation of Advanced US Tools in Assessing Allograft Complications

This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

This study will focus on monitoring renal after transplantation using all US advanced technology.

Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.

Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.

Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.

Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.

Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Eligibility Criteria:
INCLUSION CRITERIA

* Patients ≥ 18 years.
* Tx patients.
* Gender.

EXCLUSION CRITERIA

* Prisoners.
* Patients \< 18 years.
* Pregnant women
A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee

This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Femorotibial osteoarthritis of the knee
* Radiological OA Kellgren-Lawrence grade 2 or 3
* WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9

Exclusion Criteria:

* Hypersensitivity to medications or to intra-articular injections
* Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
* High dose systemic corticosteroid treatment of longer (\>14 days) duration w/in 6 months of study
* Major surgery or arthroscopy of the target knee within year prior to study
* Planned surgery in the target knee within the next 3 months
* Concomitant inflammatory disease affecting either knee
International Takotsubo Registry (InterTAK Registry)

This is a multicenter, multinational, prospective and retrospective, observational study of patients with Takotsubo cardiomyopathy (TTC).

Data on natural profile (demographical characteristics, clinical phenotype, laboratory values, electrocardiography parameters, echocardiography parameters, coronary angiography parameters, medication) and outcome are systematically collected.

Our aim is to gain a better insight into the clinical profile and pathophysiology of TTC.

Registry is an open-ended study and eligible individuals are assessed at index event and follow-up on their phenotypical characteristics. Furthermore, outcome data are collected (by clinical visits or telephone follow-up).

In addition, participants are given the option to consent to the donation of biosamples for the purposes to identify TTC specific biomarkers and mutations (sub-study on behalf of the registry).

Eligibility Criteria:
Inclusion criteria: Mayo Clinic Diagnostic Criteria (Prasad et al. American Heart Journal 2008)

1. Transient hypokinesis, akinesis, or dyskinesis of the left ventricular mid segments with or without apical involvement; the regional wall motion abnormalities extend beyond a single epicardial vascular distribution; a stressful trigger is often, but not always present.\*
2. Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture. †
3. New electrocardiographic abnormalities (either ST-segment elevation and/or T-wave inversion) or modest elevation in cardiac troponin.

In both of the above circumstances, the diagnosis of TTC should be made with caution, and a clear stressful precipitating trigger must be sought. \* There are rare exceptions to these criteria such as those patients in whom the regional wall motion abnormality is limited to a single coronary territory.

† It is possible that a patient with obstructive coronary atherosclerosis may also develop TTC.

Exclusion criteria: Patients with Myocarditis