cyrilzakka/clinical-trials huggingface dataset:
Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study.
2. Considered by the Investigator to not be a suitable candidate for participation.
Physiotherapy in the Haemophilic Arthropathy of the Elbow.

The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation (PNF), and the other with education sessions and home exercises, for the improvement of the ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of the elbow.

The intervention was carried out during twelve weeks, performing evaluations before and after treatment, and six months of finalizing this. The treatment of MT group consisted of two sessions per week, one hour each, and the treatment of group E consisted in a session for 90 minutes every two weeks, with daily home exercises. The control group (group C) did not receive any intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients diagnosed with hemophilia A or B
* Patients with hemophilic arthropathy in one or both elbows

Exclusion Criteria:

* Patients with another medical diagnosis (eg, Von Willebrand's disease)
* Patients with presence of antibodies to FVIII or FIX (inhibitors)
* Patients who had a haemarthrosis of elbow during the study
Teicoplanin Allergy Testing Using Autologous Serum (TATAS)

Allergy testing for Teicoplanin is much more unreliable than for other similar drugs. This means that we run the risk of missing serious Teicoplanin allergy, and these patients will be given another dose in future, not knowing that they are seriously allergic. Serious allergic reactions, also known as anaphylaxis, can be life threatening.

The patients which we recruit to our study will come to us through the perioperative allergy service. They will have had a reaction to a general anaesthetic, but will also have had teicoplanin as part of the anaesthetic.

We are not sure why allergy skin testing, which is fairly reliable for most other drugs, is so unreliable in detecting teicoplanin allergy. We do know that some drugs need to mix with proteins in the blood before they trigger an allergy. We would like to replicate this by mixing the teicoplanin with the patients' own blood and using this for the skin testing, to see if we get a more reliable result compared with the plain drug. Using the patient's own serum to do skin testing is an established test (the 'autologous serum test') used in certain immunological conditions, we are simply going to use it as a vehicle to test our theory.

We will recruit 20 adult patients referred with a recent history of anaphylaxis under anaesthesia, where teicoplanin has been given and is one of the drugs under suspicion of having caused the allergy. In addition to the usual allergy skin testing, which would be done anyway as part of standard allergy investigation, we will perform extra tests using autologous serum for this trial.

We hope to find a better way of testing for Teicoplanin allergy, so that patients are not put at risk where the allergy has been missed because of an unreliable test.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given

Exclusion Criteria:

* Patients unable to stop drugs that would interfere with skin tests prior to study- e.g. antihistamines or certain anti-psychotics
* Pregnancy
* Patients under age 18 years
* Patients with elevated baseline mast cell tryptase requiring further investigation
* Patients with blood-borne viruses such as Hep B, C and HIV
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).

To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.

There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
* Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
* HFrEF defined by documented evidence of EF ≤ 40% OR
* HFpEF defined by documented evidence of:
* EF ≥ 50% and no prior record of EF \< 40%
* Evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 ESC guidelines
* Able to understand and willing to provide written informed consent to participate in the trial
* Age 21 years old or greater
* Willing and able to participate in the required testing

Exclusion Criteria:

* Prior hospitalization, CV event or surgery within 6 weeks
* Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
* Patients with Active Implantable Medical Devices
* Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
* Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
* Subject is pregnant as indicated by patient record
* Patients with rash or open wound on torso locations where investigational devices will be placed
* Patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator
Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital

Effect of Negative Pressure Wound Therapy for Soft Tissue Iinjuries of Foot and Ankle in Patients at a Tertiary care Hospital.

To evaluate the effect of negative pressure wound therapy for soft tissue injuries of foot and ankle.This will be assessed through measuring the wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.

All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with or without bones and tendon exposed were included in the study. 35 patients were randomized into Negative Pressure Wound Therapy group and 35 in conventional treatment group.In NPWT group ,NPWT was applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up at 10 days ,20 days and 27 days respectively.

In Conventional treatment group patients were kept on simple moist gauze dressings and the wound was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimeter square on followup at 10 days , 20 days and 27 days respectively.

Eligibility Criteria:
Inclusion Criteria:

1. All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with bones and tendon exposed
2. Patients consenting to participate in the study

Exclusion Criteria:

1. Patients with uncontrolled diabetes mellitus
2. Patients with multiple fractures
Real-World Immuno-Radiotherapy for Advanced NSCLC

The optimal combination strategy for radiotherapy combined with immunotherapy (iRT) in advanced non-small-cell lung cancer (NSCLC) remains unclear, and there is a lack of real-world data to validate its efficacy. The objective of this study is to confirm the survival benefits of iRT in advanced NSCLC and to identify the optimal combination strategy for its use.

The PACIFIC study has established radiotherapy combined with immune checkpoint inhibitors (iRT) as the primary treatment modality for unresectable, locally advanced non-small-cell lung cancer (NSCLC). Simultaneously, the KEYNOTE-001 study provided evidence supporting the efficacy of iRT in patients with metastatic and progressive NSCLC. However, most available evidence comes from interventional clinical trials, where participants are rigorously selected and required to adhere strictly to protocol-defined interventions. This creates a significant gap in real-world data, which is essential to further validate the survival benefits of iRT in advanced NSCLC. Furthermore, clinical trials evaluating concurrent iRT in NSCLC have largely yielded negative or inconclusive results, highlighting the need for clarity on the optimal combination strategy for iRT.

To address these gaps, researchers will conduct a territory-wide real-world cohort study. The objective of this study is to validate the survival benefits of iRT in patients with advanced NSCLC and to identify the optimal sequential strategy for iRT.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC patients who received immunotherapy between 2015 and 2021
* For unresectable locally advanced NSCLC: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT or concurrently with RT
* For de novo metastatic NSCLC: radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT or concurrently with RT
* For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy
* Age \>= 18 years old

Exclusion Criteria:

* Patients with multiple primary cancers or a pathological diagnosis of small cell lung cancer
* Patients who did not receive radiotherapy or who did not undergo radiotherapy within 90 days before or after immunotherapy
Effect of Prophylactic Ketorolac on CME After Cataract Surgery

The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* First cataract surgery (i.e., first eye).

Exclusion Criteria:

* hypersensitivity to the NSAID drug class,
* pregnancy.
High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants

To determine the effects of high intensity interval training on cardiovascular function, cardio metabolic markers and cardiorespiratory fitness in healthy individuals with or without facemask


Eligibility Criteria:
Inclusion Criteria:

* Non smoker
* Free of any heart and lung diseases
* Passed Physical Activity Readiness Questionnaire PAR-Q
* To be able to do exercise

Exclusion Criteria:

* Any physical limitation that restrict exercise
* Any neurological illness
Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi

This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.

Recently, some Shock Wave Lithotripsy (SWL) devices have been announced in the market with a different focus points. One early experimental study found that stone disintegration is better with small focusing points than larger focusing points. Nevertheless, these findings, in terms of the efficacy of stone disintegration, need to be validated in-vivo. Furthermore, the effect of focal size on renal injury during SWL need to be studied as well. Therefore, the objectives of this study are to compare the effect of using the narrow focus of 2mm (F1) versus the wide focus of 8 mm (F3) on the Stone Free Rate (SFR) following SWL for renal stones 1-2cm and estimating renal injury effect of F1 vs. F3 by urinary renal injury markers such as neutrophil gelatinase-associated lipocalin (NGAL) for assessment of proximal and distal renal tubules injury \& Kidney Injury Molecule-1 (KIM-1) for assessment of proximal renal tubules injury).

The SWL device:

Lithotripter type: Piezo Lith3000 plus ( from Richard Wolf, Germany.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\>18years old) with 1-2 cm single renal stone.
2. Normal functioning kidney.

Exclusion Criteria:

1. Pregnancy.
2. Bleeding diatheses.
3. Radiolucent stones.
4. Radio-opaque stones with Hounsfield Unit (HU) \> 1200
5. Patients with a pacemaker.
6. Active Urinary Tract Infection (UTI).
7. Severe skeletal malformations.
8. Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
9. Renal artery aneurysm at the same site of the stone.
10. Anatomical obstruction distal to the stone.
11. Patients with renal impairment with serum creatinine \> 1.2 mg/dL.
Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients

Advances in orthodontics have improved the quality of appliances and treatment protocols, raising the standard of patient care. However, enamel demineralization is still a problem associated with orthodontic treatment, leading to the formation of white spot lesions; this is a grave concern to orthodontists and patients.

The overall prevalence of white spot lesions among orthodontic patients has been reported to be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments. Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S mutans), are higher in orthodontic patients than in non-orthodontic patients.

This causes demineralization around the brackets and leads to white spot lesions. They are most prevalent around the cervical region of bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are most commonly affected.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic treatment with the straight wire appliance (MBT, 0.022-in slot; 3M Unitek, Monro- via, Calif).
* Complete permanent dentition (excluding third molars).
* No chewing gum or mouthwash used in the last week and during the study.
* Habit of brushing twice daily with fluoride toothpaste.

Exclusion Criteria:

* Patient with poor periodontal condition.
* Patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.
A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)

The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary State II or Stage III breast cancer
* Patient is not receiving adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) at the time of randomization and has not received adjuvant chemotherapy for at least 6 weeks prior to the randomization visit (Visit 2). This inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7)
* Patient is not receiving hormonal therapy OR if patient is receiving hormonal therapy (e.g., leuprolide, tamoxifen, anastrozole) she is on a stable regimen for at least 3 months at the time of screening (Visit 1). If patient is HER2-positive and is receiving trastuzumab treatment, she must be on a stable regimen for at least 1 month at the time of Visit 1
* Patient is not pregnant or breast-feeding. All women of childbearing potential must have a negative urine pregnancy test at screening (Visit 1)

Exclusion Criteria:

* Bone metastases or history of bone metastases
* Patient has evidence of other distant metastases (e.g., visceral, soft-tissue, or brain)
* Patient has had a prior local or regional recurrence of her breast cancer, or a contralateral tumor. DCIS (ductal carcinoma in-situ), and LCIS (local carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted
* Patient has ANY of the following:

  1. is currently receiving a bisphosphonate or other drug therapy for osteoporosis
  2. has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to Visit 1, or for a total of more than 6 months at any time prior to Visit 1
  3. has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1
* Patient has a history of malignancy other than breast cancer \<5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are exclusionary
* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
* Patient is currently participating in or has at any time in the past participated in a breast cancer study with a registered medication (i.e., approved by the regulatory agency in which she resides) being tested for the treatment of breast cancer (an unapproved indication)
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?

Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (Zofran), is in dire national shortage. Consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. Following emergence from general anesthesia, children often request food and drink. There have been no studies to date that definitively determine the optimal first food or drink choice for these children. This study proposes to randomize children to either water or juice first intake following surgery. The investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.


Eligibility Criteria:
Inclusion Criteria:

* Dental surgery
* Tonsillectomy and adenoidectomy
* Strabismus surgery
* Age 2-18

Exclusion Criteria:

* Patient refusal
* Parent refusal
* Allergy / contraindication to ondansetron
* Prone to vomiting
* Inpatient
* Preoperative anxiolysis with ketamine
* Recovery location other than PACU
* Nil per os at baseline
* Presence of enteric tube
* Contraindication to any part of the study protocol
The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women

This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS.

We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.

30 women diagnosed for PCOS (aged 30-50 years) are enrolled for the study. 15 women are randomized in the atorvastatin group and 15 in the placebo group. The women with PCOS participating in the study are required to use safe non-hormonal contraception during the medication.

The study includes transvaginal ultrasonography, serum samples, oral glucose tolerance test (OGTT) and intra venous tolerance test (IVGTT) before and after receiving 6 months atorvastatin 20mg/day therapy or placebo.

Measurements for androgen levels, pituitary hormones, glucose, insulin and inflammatory markers are performed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed for PCOS (Rotterdam criteria)
* aged 30-50 years
* safe non-hormonal contraception

Exclusion Criteria:

* use of cholesterol lowering agents
* use of antidepressants
* use of cortisone medication (p.o.)
* use of hormonal contraception
* nursing
* pregnancy
* DM-T2
* liver disease
* menopause
* kidney or liver failure