cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome

This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.

The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 to 65 years.
* Diagnosed with piriformis syndrome.
* Experiencing chronic pain for at least 3 months.
* Willingness to comply with the study protocol and attend all therapy sessions.

Exclusion Criteria:

* Recent surgery on the lower back or hip.
* Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
* Pregnant or breastfeeding women.
* Use of anticoagulant medication or having a bleeding disorder.
* Participating in another clinical trial simultaneously
The Efficacy of MDI Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp

Our lab at McGill University has developed an optimization algorithm for T1D MDI patients that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate ratios) using glucose sensor data and insulin dosing data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and ICRs. The investigators hope that this algorithm will be able to optimize the patients' individual basal injections and ICRs in order to improve glycemic control.

The objective of this project is to compare our basal-bolus optimization algorithm with physician adjusted basal-bolus parameters using a randomized parallel clinical trial in children and adolescents at a Camp Carowanis. The investigators hypothesize that using this optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters regarding time spent in target glucose range (3.9 mmol/L - 10mmol/L).

Between 40 and 68 children and adolescent type 1 diabetes patients undergoing MDI treatment at Camp Carowanis will randomly undergo one of two interventions:

1. MDI with Physician Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy. At breakfast, the research team will download the sensor data. Camp physicians will review each participant's sensor and insulin data and make changes to their parameters based on their clinical judgement, as they would for all campers, regardless of study participation. These new parameters will be entered into the patient's camp file.
2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). At breakfast, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Camp physicians will review the algorithm's recommendations before they are entered into the patient's camp file.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 8 and 18 years old.
2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
3. Undergoing multiple daily injection therapy.
4. HbA1c ≤ 11%.

Exclusion Criteria:

1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
2. Failure to comply with the study protocol or with team's recommendations.
3. Injection of isophane insulin (NPH) or any intermediate-acting insulin
4. More than one injection of slow-acting insulin per day.
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age or older
* able and willing to follow instructions, including participation in study assessments and able be present for the required study visits for the duration of the study
* If female and of childbearing potential, were not pregnant, nursing, or planning a pregnancy. Women of childbearing potential were required to have a negative urine pregnancy test at the pre-screen visit and had to agree to use an acceptable method of mechanical or hormonal contraceptive for the duration of the study
* a diagnosis of dry eye
* a history of intermittent or regular artificial tear use within the past 3 months
* best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in one or both eyes
* a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 OR a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 with a conjunctival redness score of ≥ 1.5+ at Visit 1 and before CAE exposure at Visits 2 and 3 in at least one eye
* Demonstrated a response when exposed to the CAE at Visits 2 and 3

Exclusion Criteria:

* clinically significant blepharitis or Meibomian Gland Dysfunction (MGD) or lid margin inflammation, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
* diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis), or preauricular lymphadenopathy, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
* Reported an ocular discomfort score of 4+ in both eyes at time 0 of CAE exposure at Visits 2 or 3
* Wore contact lenses and refused to remove them for the duration of the study
* previous laser in situ keratomileusis (LASIK) surgery
* currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and could not discontinue these medications for the duration of the study
* presently taking any medication known to cause ocular drying that had not been a stable dose for at least 30 days
* currently taking oral antihistamines that could not be discontinued during the study
* a systemic disease, uncontrolled medical condition that in the opinion of the investigator could interfere with study measurements or subject compliance
* received another experimental drug or device within 30 days prior to screening
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery

In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?

Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.

This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.

This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.

Eligibility Criteria:
Inclusion criteria:

* Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
* Body Mass Index (BMI) above 20 and below 40 kg m-2
* Age above 18 years.
* Eligible to sign informed consent.

Exclusion criteria:

* Change from scheduled morning surgery to a non-morning case or emergency surgery.
* Redo surgery.
* Off-pump surgeries.
* Pregnancy.
* Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
* Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
* Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
* Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
* Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension).
* Patients requiring mechanical ventilation for more than 24 hours postoperatively.

Criteria For Discontinuing (Postoperative Exclusion Criteria):

* Prolonged cardiopulmonary bypass (CPB) of more than three hours.
* Transfusion of more than three units of blood products.
* Severe coagulation disturbance requiring prothrombin complex concentrate or recombinant factor VII.
* Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the surgery of ≥ 20.
* Right ventricular failure requires inhaled nitric oxide.
* Need for mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation).
Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment

This is an observational, prospective, multicentre and nationwide study.

The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.

Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions.

The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
* 2. Tumor should be considered resectable before study entry by a multidisciplinary team
* 3. ECOG 0-1
* 4. Age ≥ 18 years at time of study entry
* 5. Patients that are going to be treated with neoadjuvant treatment before surgery
* 6. Patient capable of proper therapeutic compliance and accessible for correct follow-up
* 7. Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

* 1. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
* 2. No possibility of venipuncture
* 3. Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
Oocyte Cryopreservation

The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.


Eligibility Criteria:
Inclusion Criteria:

Any consenting female who wishes to freeze unfertilized oocytes and are:

1. at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
2. a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
3. a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
4. a donor egg recipient who elects to have some of the eggs obtained fertilized with husband/partner sperm and the rest cryopreserved for future use.
5. a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
6. a patient who, for religious or ethical reasons, wants to limit the number of fresh oocytes exposed to sperm (fertilization) and do not want to either discard or donate the excess oocytes.

AND

1. has been clinically and psychologically approved for ovarian stimulation
2. age between 12 and 42 years, inclusive, at time of informed consent.
3. willing and able to comply with the protocol.
4. willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis results, as well as information on obstetrical outcome.
5. agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.

For cancer patients:

1. No significant ovarian pathology as judged by physical exam and radiological studies;
2. Patient's general condition and prognosis deemed favorable for surgery and chemo/radio therapy;
3. No other major medical illness,
4. Oncologist approval for the ovarian stimulation and egg retrieval.

Exclusion Criteria:

Age \> 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this study.
Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs

In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.

There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.

There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.

The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.

In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years of age
* Patient with CRPS of at least one upper limb
* Patient affiliated to a Social Security plan
* Patient who has signed and dated the no-objection form
* Patient with the cognitive ability to understand the treatment and complete the questionnaires
* Patient who can be followed for a minimum of 1 year

Exclusion Criteria:

* Patient with an uncontrolled infection
* Pregnant or breastfeeding patient
* Patient who has already undergone treatment by spinal cord stimulation
* Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
* Patient who cannot be followed regularly for psychological, social, family or geographical reasons
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Safety and Tolerability of PRO-185

Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.

A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Being clinically healthy
* Having the ability to grant a signed informed consent
* Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
* Age between 18 and 45 years
* Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
* Best corrected visual acuity equal of better than 20/30 in both eyes.
* Vital signs within normal ranges.
* Intraocular pressure ≥10 and ≤ 21 mmHg

Exclusion Criteria:

* Using any kind of topic ophthalmic products
* Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
* History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
* History of iridotomies or waiting for this procedure to take place.
* Conjunctival hyperemia grade 3 or 4 according to Efron scale.
* Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
* Using medications or herbology products, through any route of administration.
* Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
* Previous participation in any clinical study 90 days prior to the inclusion in the present study.
* Previous participation in this study.
* Using contact lenses which cannot be suspended during the period of this study.
* History of any chronic illness, including diabetes and hypertension.
* Active inflammation or infection at the time of inclusion in this study.
* Unresolved lesions or traumas at the moment of inclusion in this study.
* History of any kind of ocular surgery.
* History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects.

Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment.

This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate.
* Patients must have a PSA failure defined as PSA of \>= 0.5 ng/ml that has increased above nadir following radical prostatectomy (RP); or a PSA increase of 2.0 above post-therapy nadir after radiotherapy (RT); or a PSA increase between 0.05-0.49 ng/ml that has increased above nadir following RP. The maximal PSA value at enrolment must be \<5.0 ng/mL after RP and \<6 ng/mL after RT.
* PSA value must be increasing based on three consecutive measurements each separated by at least 4 weeks prior to enrolment to this study.
* Patients may have received any number of local therapies (RP, external beam RT or brachytherapy).
* Provide written informed consent.

Exclusion Criteria:

* Patients with evidence of metastatic disease.
* Patients who have received prior cytotoxic chemotherapy for recurrent disease.
* Patients currently receiving biological response modifiers, or corticosteroids.
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
* Use of omega-3 or any other dietary supplements for the previous 3 months and during study is not allowed.
* Known allergy to fish or shellfish or sunflower.