cyrilzakka/clinical-trials huggingface dataset:
Evaluating Piezo-ICSI. - The EPI Study.

Intracytoplasmic sperm injection (ICSI) has successfully been used to treat both severe male infertility and fertilization failure since its introduction in the early 1990´s. During the procedure a single sperm is injected into the cytoplasm of an oocyte to achieve fertilization. This technique is intrusive, has a relatively long learning curve and variable operator performance.

A new injection technique called piezo-ICSI has recently been introduced. During piezo-ICSI, a piezo-electric effect is generated through the conversion of electric energy to mechanical energy. This causes a smooth movement of the injection pipette, which allows for steady, controlled microinjections with less psychical stress applied on the oocytes than by the conventional technique.

A recent analysis, based on data from 9 different studies comparing conventional ICSI and piezo-ICSI (17500 cases), showed a benefit of piezo. Unfortunately, proper randomized trials are missing from this analysis. The proposed study is a randomized controlled study carried out at two private IVF clinics. Eligible participants are patients undergoing ICSI treatment, with a minimum of 6 oocytes. The participants will act as their own controls, with their oocytes randomly and equally divided between injection by the investigated and the conventional technique.

Whether piezo-ICSI is associated with improved success rates or reduction in adverse outcomes is at present unclear. Patients with fragile oocytes may benefit more from piezo-ICSI. In patients above 35 years, piezo-ICSI has been associated with a lower oocyte degeneration rate and an increased blastocyst rate. The aim of the study is to investigate whether the piezo-ICSI technique will result in more oocytes becoming normally fertilized compared to conventional ICSI. Another proposed benefit of piezo-ICSI lies in the standardization and simplification of the ICSI procedure. Making the injection procedure more independent of operator skill may result in a more robust and predictable laboratory output.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving controlled ovarian stimulation with gonadotrophins needing ICSI for fertilizing oocytes.
2. Availability of at least six mature oocytes (MII) after oocyte pick-up.
3. Planned blastocyst culture.

Exclusion Criteria:

1. Intention to perform any form of preimplantation genetic testing
2. The use of IMSI or polarized light in the ICSI process
3. The use of assisted hatching prior to randomization.
4. Surgical sperm retrieval (SSR) patients.
5. Previous participation in this RCT
6. Concurrent participation in another investigation that can affect the primary outcome of this study.
7. Sperm sample with \<0.1million/ml or motility of \<2% after preparation.
8. Fertility preservation cycles.
9. If a day 2-4 transfer is planned
10. Use of vitrified oocytes.
Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination.

A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed.

The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

In order to be able to interpret the results on a homogeneous population, given that several molecules have marketing authorization for the management of macular edema following a CRVO, the therapeutic management will be standardized by the use of aflibercept for patients requiring intravitreal injection, aflibercept being the most widely referenced treatment currently used in the participating centers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CRVO, with or without macular edema.
* Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
* Naive of intravitreal injection and intravitreal corticosteroid implant
* If woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept

Exclusion Criteria:

* Pregnant or breastfeeding woman
* History of stroke or myocardial infarction in the last 3 months
* Retinal detachment or untreated retinal dehiscence
* Opacity of ocular media
* Amblyopia
* Diabetic retinopathy
* Macular edema of a different etiology than CRVO
* Active or suspected ocular or periocular infection
* Severe intraocular inflammation
* Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male Volunteers;
* Age ≥18 years and ≤45 years;
* BMI ≥20- ≤30 kg/m²
* No clinically significant screening observations

Exclusion Criteria:

* Female volunteers;
* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results;
* History of allergy or major allergic reactions considered to be clinically significant by the Investigator;
* Any screening assessment determined to be clinically significant by the Investigator;
* Donate blood within 60 days of screening or otherwise experienced blood loss \>250 mL within the same period;
Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

This study aimed to investigate the relationship between fatty infiltration in the lumbar paraspinal (multifidus and erector spinae) muscles, clinical characteristics, and treatment response after lumbar erector spinae plane block (ESPB) in patients with low back pain due to lumbar radiculopathy. A responder was defined as a patient with a numerical rating scale (NRS) decrease of ≥ 50% from baseline to one month after the procedure. The presence of fat infiltration in the lumbar paraspinal muscles was assessed, along with patient demographic and clinical characteristics.

Low back pain (LBP) is a common health problem that causes global disability. Lumbosacral radiculopathy (LR) is the most common cause of low back pain. Disc herniation is the most common cause of LR, in addition to spinal stenosis, foraminal stenosis, facet joint hypertrophy, and degenerative disease (1). Treatment options for lumbar disc herniation include conservative treatment, interventional pain management, and surgery. Lumbar erector spinae plane block (ESPB) is an interventional procedure for chronic axial and radicular low back pain which that is unresponsive to conservative treatment.

Lumbar paraspinal muscles play an important role in maintaining lumbar spine stability. Increased fat infiltration in the paraspinal muscles has been associated with high-intensity low back pain and poor functional status, and fat infiltration in the paraspinal muscles can be detected by lumbar magnetic resonance imaging. In this study, fatty infiltration in the bilateral lumbar multifidus muscles was evaluated at the L3 level using Goutallier classification.

The primary aim of this study was to investigate the potential relationship between the treatment outcome of lumbar ESPB and the degree of fatty infiltration in the paraspinal muscles in patients with chronic axial and/or radicular low back pain unresponsive to conservative treatments. The secondary aim was to identify other factors that may be associated with a successful response to lumbar ESPB and fatty infiltration of the paraspinal muscles.

Eligibility Criteria:
Inclusion Criteria:

* lumbar radicular pain
* no response to conservative treatment for \> 3 months
* MRI within 1 year prior to injection.

Exclusion Criteria:

* inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
* patients lost to follow-up within one month after lumbar ESPB
* patients with a history of surgery for lumbar disc herniation
* patients with severe spinal and/or foraminal stenosis
* patients with extruded, sequestrated, or migrating hernias.
A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring

The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of urinary urgency
* Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
* Symptoms of overactive bladder for greater than or equal to 6 months

Exclusion Criteria:

* Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
* An average volume voided of \>200 ml per micturition as verified on the micturition chart before randomization
* Total daily urine volume of \>3000 ml as verified on the micturition chart before randomization
Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study

Disease-related malnutrition (DRM) can occur when there is a deficient supply of energy, protein and/or other nutrients, depending on the nutritional needs of each individual at different times of their life cycle or health or disease circumstances. This deficiency induces effects on body composition and tissue and organ function and results in clinical consequences: increased morbidity and mortality associated with different disease processes.

There are techniques for nutritional assessment using assessment tools aimed at morphofunctional diagnosis of malnutrition, in addition to the classical nutritional parameters, such as weight loss, BMI, folds, circumferences, albumin, lymphocytes, cholesterol and intake. New advanced parameters are being incorporated into clinical nutrition and their incorporation into clinical practice is of increasing interest, such as measures derived from bioelectrical impedance (BIA) and phase angle (PhA), dynamometry, functional tests, CRP/prealbumin ratio and muscle ultrasound.

In 2019, the GLIM criteria were published, providing a different vision of how to assess the malnourished patient. Phenotypic criteria include reduction in muscle mass (measured using validated techniques to measure body composition).

The objective of the study is to highlight nutritional ultrasound for measuring muscle and functional status in order to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in this type of patients.

Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital who in the first week of admission have moderate or high risk of malnutrition according to the MUST and SARC-F screening test using R-MAPP. Appendix
* Patient aged 18 to 85 years.
* Patient who agrees to participate in the study and signs the informed consent.

Exclusion Criteria:

* Hepatic impairment (AST/ALT 3 x upper limit of normal)
* Chronic kidney failure (GFR \<45 mL/min)
* Patient with previous ICU stay during the study admission.
* Cancer patients on palliative treatment or ECOG (Eastern Cooperative Oncology Group) ≥ 3.
* Orthopaedic disease that does not allow adequate walking
* Patients with known dementia or others not related to a significant neurological or psychiatric disorder, or any other psychological condition that may interfere with the conduct of the study.
* Patients with eating disorders
* Life expectancy of less than 6 months.
* Patients unable to adequately complete the clinical laboratory assessments required for the study protocol.
Pain Control of Thoracoscopic Major Pulmonary Resection

The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Eligibility Criteria:
Inclusion Criteria:

* patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity

Exclusion Criteria:

* not done by VATS anatomical resection
* patient does not agree to the study
* postoperative hospital stay exceeds 7 days due to postoperative complications
* existence of preoperative renal insufficiency (Cr \> 1.5)
* OT/PT \> 120
* history of Lidocaine hypersensitivity
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy

Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1,2 Age 20-65

Exclusion Criteria:

* emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection
Follow-up Study for Participants of Jointstem Investigator Initiated Trial by Arthroscopy

This clinical trial is conducted to assess the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.

JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

This clinical trial is planned to follow-up the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.

Subjects who participate in the BS-JS-IIT1 study and agree to this extension test in writing will be assessed for safety by conducting laboratory tests, vital signs, physical examinations and adverse events every 12 months after Visit 1.

However, after unblinding of the BS-JS-IIT1 investigator initiated trial, subjects in the control group (placebo administration) will terminate the follow-up of this extended clinical trial and conduct routine treatment for degenerative knee arthritis at the discretion of the researcher. Appropriate measures and follow-up observations shall be implemented for abnormal reactions occurred during this extended test period until they are terminated (such as the loss of the relevant adverse event or inability to conduct follow-up investigations).

Eligibility Criteria:
Inclusion Criteria:

* Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
* Participants who signed informed consent document of this study

Exclusion Criteria:

* No applicable
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Total investigator global assessment (IGA) \>=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

* Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
* Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
Individual Following in Anal Cancer With PET/CT

Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement.

The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.

Post-treatment 18-FDG PET scan at 2 months can prove useful to predict locoregional or metastatic recurrence in patients treated by radiochemotherapy or radiotherapy in the anal canal cancer setting. There appear to be an FDG intensity variable and a metabolic response criterion enabling establishment of two groups of patients: low recurrence risk versus high recurrence risk at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive inclusion of incident cases of anal canal cancer between November 2014 and May 2018. These patients are volunteers and have signed informed consent.

Exclusion Criteria:

* Presence of a nother cancer and specific treatment (chemotherapy, radiotherapy). Follow-up impossible during two years or more.

Refusal to submit to initial or post-treatment PET/CT.
Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.


Eligibility Criteria:
Inclusion:

* Men and nonlactating and nonpregnant women greater than or equal to 18 years of age.
* Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG).
* Have a high probability for compliance with and completion of the study.

Exclusion:

* Subjects with chronic osteomyelitis.
* Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines.
* Involvement in other investigational studies of any type within 30 days before test article administration.
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acne vulgaris
* Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

* Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
* Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
* Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
* Use of birth control pills strictly for acne control