cyrilzakka/clinical-trials huggingface dataset:
Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

The purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

It is generally the case that smaller corneal cataract surgical incisions are associated with more rapid wound healing, more stable corneal biomechanical properties and less surgically induced astigmatism (SIA). With the development of phacoemulsification and foldable intraocular lenses (IOL) during recent decades, the size of clear corneal incisions has been reduced from 3.2-mm (coaxial small incision) to 1.4-mm (bimanual micro incision). Micro incision cataract surgery (MICS), including bimanual and micro coaxial phacoemulsification, has attracted much interest recently, due to its safety and ease of learning. However, the superiority of coaxial micro incision cataract surgery as compared conventional coaxial cataract surgery is still not certain, because micro incision phacoemulsification may result in longer ultrasound time (UST), the use of more ultrasonic power and consequently higher endothelial cell loss (ECL).

In our previous studies of the OZil Torsional phacoemulsification system (Infinity, Alcon), we reported that the safety and effectiveness of cataract surgery are influenced by many factors, including the blade used to create the incision, the phacoemulsification apparatus, and the IOL and mode of IOL delivery, which together constitute a surgical system, whose outcomes are restricted by the best performance of each component. Today, micro coaxial phacoemulsification is in wide use for cataract surgery, but the lower limits of incision size should be understood in the context of the various components of the surgical system.

In this study, we compared the safety and efficacy of three different incision-size-dependent phacoemulsification systems, 1.8, 2.2 and 3.0 mm, and evaluated the relationship between incision size and SIA.

Eligibility Criteria:
Inclusion Criteria:

* age between 55 and 85 years
* the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (Lens Opacities Classification System III)
* a transparent central cornea
* pupil dilating to \>= 7 mm at the time of preoperative examination
* a preoperative central endothelial cell count of \>= 1500 cells per square millimeter

Exclusion Criteria:

* previous intraocular surgery
* glaucoma
* pseudoexfoliation
* uveitis
* high myopia
* diabetes mellitus
Transnasal Sphenopalatine Ganglia Block for Management of Chronic Migraines in Pediatric Patients

Single-center, open-label, pre-post treatment pilot study to evaluate the safety and effectiveness of sphenopalatine ganglia blocks for the treatment of chronic migraine in the pediatric population. 50 children with a diagnosis of chronic migraines will undergo a series of three transnasal sphenopalatine ganglia blocks to measure their effect on headache frequency, headache intensity, headache duration, and use of headache medication.


Eligibility Criteria:
Inclusion Criteria:

Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks.

Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age

Exclusion Criteria:

Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy
Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries

Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications .

There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block.

TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries.It is safer technique than PVB, but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .

Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of post operative respiratory complications . A lot of patients presented to these operations may have comorbidities as impaired renal function and respiratory problems , conditions like these may contraindicate aministration of systemic analgesia as opioids .

There are a lot of techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block .

Paravertebral block is effective technique for post operative analgesia for upper abdominal surgeries , but it may be associated with some complications as : pneumothorax , spread of local anesthetic to the epidural space and paravertebral blood vessels , and this may lead to systemic toxicity of local anesthetic .

TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries , but it is safer technique than PVB , but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 60 years
* ASA I-II class

Exclusion Criteria:

* Patient refusal
* Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site)
* Patients with allergy to amide local anesthetics or medication included in the study.
Manual Therapy in Tension-type Headache

Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in TTH management

Increased cranio-cervical muscle sensitivity is the most prominent finding in TTH. Also, neck pain is markedly more common in individuals with TTH compared with the control population (88.4%, and 56.7%, respectively). Therefore, current research on the pathogenesis of TTH focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. It has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (CNS) due to long-term nociceptive stimuli may play a role in development and chronification of TTH

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of TTH was made based on the International Classification of Headache Disorders criteria, third edition (ICHD-3 beta)
* (bilateral localization, pressing and tightening pain, mild-moderate intensity \[≤7.0 on a visual analog scale (VAS)\]
* no increase in pain during physical activity
* patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ICHD-III diagnostic criteria
* had symptoms for more than 3 months
* the patients had to have had at least one segmental dysfunction of the upper cervical spine in all groups (by functional and pain-provocation tests).

Exclusion Criteria:

* any other primary or secondary headache according to the ICHD-III criteria
* a history of neck or head trauma (e.g., whiplash)
* any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use)
* diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis)
* prior surgery to the cervical spine
* application of other treatment methods such as physical therapy or anesthetic block to the head and neck area within the last 3 months
* initiation of pharmacologic prophylaxis within two months prior to randomization
* pregnancy
Long-term Study of DSP-5423P in Patients With Schizophrenia

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
* Patients who are aged 18 years or older at informed consent
* Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.

Exclusion Criteria:

* Patients who fall under a contraindication listed in the LONASEN® package insert
* Patients with Parkinson disease, etc.
Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

The aim of this study is to evaluate the efficacy of liposomal bupivicaine in post operative analgesia for patients undergoing bariatric surgery when compared to conventional local analgesia. Patients will be randomly selected to receive either liposomal bupivicaine or conventional bupivicaine via a transversus abdominal plane block during surgery. Patients will be followed post-operatively to assess use of narcotics, post-operative pain and nausea scores, and length of stay.

Optimizing pain management following bariatric surgery is an important aspect of patient care and post-surgical recovery. Despite advances in post-operative pain management, this remains a challenge and opioids continue to dominate as the most widely used analgesia for post-surgical pain management. Opioid use especially in the opioid-naive patient carries significant short term and long term risks including over dependence and chronic opioid use.

Movements towards minimizing post-operative opioid use has shown regional anesthetic techniques to be highly effective in the management of pain in surgical patients. More specifically, liposomal bupivicaine (Exparel) is a novel non-opioid local analgesia that takes advantage of a multi-vesicular liposomal system to provide extended analgesia release over 72-96 hours.

The purpose of this study to evaluate the use of liposomal bupivicaine in the management of post-operative pain following bariatric surgery via a transversus abdominis plane (TAP) block. Patients will be randomized to receiving either liposomal bupivicaine or traditional 0.25% bupivicaine locally infiltrated at the time of bariatric surgery. Both liposomal bupivicaine and traditional bupivicaine will be administered via TAP block after identification of planes via laparoscopy by the bariatric surgeon.

Patients will be followed post-operatively to assess use of opioid analgesia between the two arms. In addition, they will be assessed with respect to pain and nausea using analog scores, as well as hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* The patient previously met NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
* The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

* Inability to give informed consent
* ASA \> 4
* Planned procedure other than Roux-en-Y gastric bypass (RYGB) or contraindications to RYGB
* BMI \> 55 kg/m2
* Revisional procedure
* Allergies or suspected allergies to local anesthetic medications (bupivicaine)
* Renal insufficiency (GFR \< 30ml/min)
* History of chronic pain needing daily medications for the last \>3 months
Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children

This is a single-blind randomized controlled trial, aiming to evaluate the effects of vaginal seeding on body mass index as well as allergy risk for cesarean-delivered infants. It will be conducted in Liuyang city of China, and the targeted sample size is 106. All the eligible pregnant women will be randomly assigned to either the intervention or control group, and their babies of the participants will be followed up to 24 months of age.

Many studies have suggested that caesarean-delivered children are at higher risks of developing metabolic and allergic diseases like obesity and asthma, possibly because newborns born by caesarean section were lack of exposure to maternal vaginal flora. It is needed to explore a simple, convenient, and safe intervention strategy to reduce caesarean-related risks. In a recent non-randomized study, the authors found that exposure of caesarean-delivered newborns to maternal vaginal fluid at birth (i.e., vaginal seeding) could partially restore the microbiota of them at 30 days after births, but the long-term health consequences of restoring the microbiota of caesarean-delivered infants remain unclear.

In this randomized study, the investigators aim to examine whether the changes in newborns' microbiota will persist to 24 month of age, and whether vaginal seeding will have any effects on body mass index and allergy risk from birth to 24 months of age. the investigators will enroll a total of 106 pregnant women, and the participants' infants will be followed up at 0 (before hospital discharge), 6, 12, 18 and 24 months. At each follow-up visit, a questionnaire survey including information on feeding, medication, and allergic status will be conducted, infants' height and weight will be measured, and feces will be collected. At 18-month-old visit, infants' venous blood will be also collected for the assay of multiallergen. The primary outcomes were body mass index and allergy risk index. The secondary outcomes included the microbiota profile, allergic symptoms and diseases, overweight/obesity, and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* local resident in Liuyang city
* Singleton, term pregnancy (≥37 weeks of gestation)
* Cesarean section before labor starts without maternal complications, or cesarean section after the start of labor but the cervix is less than 3 cm
* Vaginal pH\< 4.5 at enrollment

Exclusion Criteria:

* Positive testing for HIV, HBV, syphilis or GBS infection at gestation
* Vaginal infections such as genital herpetic lesions or chlamydia
* Bacterial vaginosis
* Trichomonas or fungous in leucorrhea
* Pregnant women or her spouse with severe allergic diseases, such as asthma and severe drug allergy
* Vaginal pH ≥4.5 at 1-2 hours before the cesarean section
* Other conditions not suitable for intervention as judged by obstetricians
A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* ECOG performance status of 0 or 1
* Histologically or cytologically documented advanced or metastatic solid tumors for which established therapy either does not exist or has proven ineffective or intolerable
* Measurable disease by RECIST v1.1 with at least one measurable target lesion

Exclusion Criteria:

* Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DLYE5953A
* Oral kinase inhibitors approved by local regulatory authorities may be used within 2 weeks prior to initiation of DLYE5953A, provided that any clinically relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor
HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms

This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.


Eligibility Criteria:
Key Eligibility Criteria:

1. at least 50 years of age on the day of the screening event
2. informed of the nature of the study, agrees to its provisions, and has provided written informed consent
3. does not have any conditions that would interfere with obtaining an echocardiogram of the heart
Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.

Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants
* over 12 hours of life
* intubated
* clinically stable
* without use of analgesics or sedatives

Exclusion Criteria:

* preterms with congenital malformations
* preterms with genetic syndromes
* preterms with Apgar score at 5´\<7
* preterms with meningitis
* preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente
Once-a-day Immunosuppression(CISECON_a_day)

The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.

This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago.
* Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor.
* Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy.
* Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans.

Exclusion Criteria:

* HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor.
* History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment.
* Having received other investigational product within 30 days prior to enrollment into this study.
* Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives.
* Having uncontrolled diseases or medical conditions requiring continuous treatment.
* History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness.
* Absolute neutrophil count \<1,500/mm3 or leukocyte count \<2,500/mm3 or platelet count \<75,000/mm3 at screening or severe metabolic disorders (including functional disorders).
* Having experienced the following condition within the past 1 month:

  * Serum creatinine \> 2.0 mg/dl more than twice.
  * 24 hr urine protein≥750 mg/day
  * Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.
ICG Fluorescence Imaging in Lower Extremity Amputation Patients

This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.

This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older
2. Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
3. Provision of informed consent

Exclusion Criteria:

1. Iodine allergy
2. Pregnant women