cyrilzakka/clinical-trials huggingface dataset:
To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation

Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. The sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high DNA fragmentation index (DFI). Hence, this study aimed at determining the efficiency of MASS in improving the clinical outcome of patients with high DFI).

Patients will be recruited from our reproductive medicine center in Nanjing Drum towel Hospital, from July 2019 to July 2020. After semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (DGC) with swim up, and the observation group will be screened by MASS, followed by DGC. Then the procedure of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) will be performed. Embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. The clinical outcomes after transplantation will be followed up.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnostic as infertile according to 2007 WHO guidelines;
* DFI\>25%.

Exclusion Criteria:

* With obvious female infertile factors;
* Sperm count \<10 million;
* Chromosomal abnormalities in either or both of the couple;
* Loss of follow up or incomplete information of patients.
Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Being conscious,
* Ability to understand and speak Turkish and not have hearing or visual impairment,
* Agreeing to participate in the research.

Exclusion Criteria:

* Having a diagnosed psychiatric and mental illness,
* Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
* Patients who do not want to continue the study
Video Analysis of Vaginal Deliveries

Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women,
* at least 18 years of age (yoa),
* term deliveries (at least 37+0 weeks of gestation),
* vaginal delivery,
* fetal vertex presentation,
* single pregnancy

Exclusion Criteria:

* younger than 18 yoa,
* preterm deliveries,
* cesarean sections,
* fetal malformations,
* maternal disease in form of collagenosis,
* multiples pregnancy,
* vaginal/vulvar/perineal pre-operations (excluding birth trauma),
* perineal birth trauma grade III+IV
Combined Management in ALI ( Image Guided Thrombectomy With Open Transfemoral Access )

Acute limb ischemia (ALI) is a sudden decrease in limb perfusion due to either an embolic or a thrombotic vascular occlusion, defined as the presence of symptoms within two weeks of onset. The profound ischemia represents an emergency in which delayed treatment results in limb loss and, potentially, death. Therefore, timely diagnosis and proper treatments for ALI are important.

Both surgical thrombectomy and endovascular treatment have benefits and drawbacks. Surgical thrombectomy using Fogarty embolectomy catheter has been the standard therapy because it is rapid and effective in cases of embolic ALI. However, blind surgical thrombectomy can result in poor revascularization or unexpected vascular injury in the presence of underlying arterial atherosclerosis or in the presence of subacute and chronic thrombi. In addition, thrombosis of runoff vessels is difficult to remove.

Endovascular management using catheter-directed thrombolysis (CDT) has emerged as an alternative to surgery. It is less invasive, and does not directly damage the vascular endothelium with the capacity to clear thrombus in the small vessels. However, long treatment duration may worsen the clinical situation. Besides, a thrombus of more than two weeks does not respond well to the thrombolysis, and it is difficult to determine the exact stage of thrombus according to the clinical history. These problems may be minimized by combined treatment, which includes surgical thrombectomy and endovascular treatment.

The aim of our research is to evaluate the effectiveness and safety of combined treatment (surgical thrombectomy and endovascular treatment) for ALI with various clinical considerations

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute onset of lower limb pain with various degrees of movement compromise.
* History of intermittent claudication with a sudden worsening of claudication and pain at rest for less than one month.
* Patients with Duplex or MSCT angiography of the lower limbs showing embolic events on healthy vessels or thrombosis of diseased vessels with or without collateralization.
* Thrombus in a poor location that is difficult to be removed by surgical thrombectomy alone.
* Acute lower limb ischemia due to acute arterial graft occlusion

Exclusion Criteria:

* - Medically compromised patients, not fit for the intervention.
* Patients with critical chronic limb ischemia (grade III, IV).
* Patients with known vasculitis or lab investigations suggesting vasculitis before treating the cause.
* Patients who refused the intervention.
Outcome of Fetal Spina Bifida

Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to long-time survival. Concerning psychomotor development as well as urinary bladder and intestinal morbidity the prognosis ranges from normal functional outcome to severe disability.

The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound screening allows patients to prepare for the birth of an impaired child or to consider termination of the pregnancy. In current practice, prenatal counseling and obstetric management depend not only on the detection of a spinal dysraphism but also on an appropriate assessment of the severity of the defect and its possible impact on the postnatal development of the affected child.

Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on the postnatal outcome. Previous studies reported that postnatally determined lesion levels correlated well with functional status and survival. On the contrary, it is still not clear whether similar data obtained antenatally are of value.

In this study, the investigators will review their database of all cases of prenatally diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the prenatal and postnatal characteristics of fetuses with spina bifida in relation to the anatomic level of the lesion, the investigators aim to contribute further information regarding the natural course of affected pregnancies and the correlation of prenatal ultrasound findings with their functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* spina bifida identified at prenatal ultrasound examination
* ultrasound diagnosis between 1993 - 2009

Exclusion Criteria:

* deviant postnatal diagnosis
* loss to follow-up
* incomplete data
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility Criteria:
Key Inclusion criteria

* OA of the knee Key Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.

The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age greater than or equal to 18 years;
* Female participants, post-menarche;
* Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
* Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
* Normal vaginal pH;
* Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Virgin participants;
* Postmenopausal participants or with vaginal atrophy;
* Participants with other vaginal infections;
* Participants with recurrent vulvovaginal candidiasis;
* Participants using immunosuppressive drugs;
* Participants diagnosed with serious systemic diseases.
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects

This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance imaging in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to provide 2 forms of identification; at least 1 must have a photo.
2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
3. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion Criteria:

1. Subject has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the C-SSRS at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a family history of epilepsy.
4. Subject has evidence of any metal in the body that may be contraindicated for receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical implants, previous accident resulting in metal or shrapnel lodged internally, tattoos inked with metallic dyes, or a history of metal work without using protective eyewear.
5. Subject has claustrophobia or a history of claustrophobia.
6. Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* Children 3 to 6 years with diagnosis F84.0 and F84.1 according to ICD-10. The diagnosis should be made according to the criteria established by the recommendations on the diagnosis (FFP / HAS 2005).
* Children supported in care units that meet the criteria defined integrative practices.
* Children receiving a volume of hours of intervention between two and four half-days per week.
* Written parental consent collection.

Exclusion Criteria:

* Presence of co-morbidities such epilepsia, serious organ damage, somatic and sensory.
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

Acute pain may occur due to trauma, surgery, infection, disruption of blood circulation or when there is tissue injury. It can be managed using analgesics and conduction anaesthesia, which may be preferable because of superior pain control and fewer side effects. Lidocaine hydrochloride is used topically to relieve itching, burning and pain from skin inflammation. This multicentric observational study is aimed to evaluate the relief gained with lidocaine hydrochloride (ORTODERMINA®) on wound pain in patients with painful wounds and to collect safety information on this treatment.

Acute pain can be managed using analgesics and conduction anaesthesia which may be preferable because of superior pain control and fewer side effects. In this contest, lidocaine hydrochloride (ORTODERMINA®) plays an important role in pain management during wound healing. The properties of ORTODERMINA® and its ability to maintain an adequate level of active drug over the lesion allow a persistent anaesthetic effect. ORTODERMINA® is a drug for topical application in the form of cream, with a high safety profile. However, although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anaesthetic agent administered.

This multicentric observational study is aimed to evaluate the relief gained with ORTODERMINA® on wound pain in patients with painful wounds and to collect safety information on this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients with painful exuding wounds \>1 cm2 that includes painful exuding ulcers and pressure ulcers grade II \[according to National Pressure Ulcer Advisory Panel (NPUAP) classification\]
* Patients available and able to return to the study site for the scheduled visits
* Patients who gave written informed consent to take part into the study

Exclusion Criteria:

* Patients with ulcer infected, discoloured, odorous, pressure ulcer grade I, III, or IV (according to NPUAP classification)
* Diabetic foot ulcer
* Patients with contraindication or known allergy to drug's components
* Patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies
* Patients who are pregnant or lactating.
* Patients with vascular disorders (mainly arteriopathies)
* Patients known as alcohol or drug abusers.
* Patients currently participating in a clinical study
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children

The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.

Pediatric migraine headache is a common cause of severe recurring headaches in children, especially children between the ages of 5 and 15 years. These headaches can be disabling and tend to interfere with a child's daily activities, such as going to school or playing with friends. Because pediatric migraine children tend to be misdiagnosed, they are often not treated effectively. Topiramate, an anti-seizure medication, has been shown to prevent migraines in adults, and it has been approved to treat seizures in children as young as 2 years of age as add-on treatment (used with another drug) and also can be used alone (monotherapy) in children as young as 10 years old. Since topiramate has already been studied in children, information about its safety in children is available. In this study, children with migraine headaches will be identified. It is not necessary for the child to have the migraine aura (having blurry vision; seeing flashing lights) to be included in this study. This is a randomized, double-blind, placebo-controlled study of Topiramate (or placebo) given for 4 to 5 months. An optional 3-month open-label extension (topiramate only; no placebo) will follow. The objective of the study is to demonstrate that topiramate is effective and safe when used to prevent migraine headaches (with or without aura) in children. Safety will be assessed throughout the study.

Topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week; increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of study (140 days total).

Eligibility Criteria:
Inclusion Criteria:

* Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)
* Average of 3 to 10 migraine days per month for previous 3 months
* Weighs more than 20 kilograms (44 pounds)
* Able to swallow a tablet whole (without crushing it)

Exclusion Criteria:

* Took topiramate previously to prevent migraines but it was not effective
* Had to stop taking topiramate because of side effects
* Presence of cluster headaches, migraine aura without headache
* Had taken any medications for migraine prevention within 2 weeks before study start
* Presence of active liver disease or abnormal kidney function
Prospective Identification and Validation of "BRCANess" Profile in Ovarian Epithelial Cancer

This is an observational prospective study. Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to select the best regions for tissue sampling to perform the following molecular studies: array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on the samples.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).

Exclusion Criteria:

* Non
Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome

The aim of this study is to assess the possible negative effects of uterine artery ligation on ovarian reserve markers and subsequent pregnancy outcomes

One of the most common surgical methods for preserving fertility is uterine artery ligation. It is simple to do and effective at reducing Postpartum hemorrhage after delivery . Additionally, it is rather safe and permits future childbearing for the patients.

Eligibility Criteria:
Inclusion Criteria:

* 120 females aged from 20 to 35 years old
* with Postpartum hemorrhage or intrapartum hemorrhage after cesarean section
* did not respond to medical therapy
* performed successful bilateral uterine artery ligation for hemorrhage management.

Exclusion Criteria:

* The presence of male factor or tubal factor.
* Hypertension, autoimmune disease, morbid obesity, absence of lactation diabetes millets, vascular disease, smoking or the use of alcohol.
* The presence of additional surgery or medical disease.
* Detection of a uterine anomaly, history of intrauterine growth restriction in previous pregnancies.
* Usage of a hormonal therapy through the research.
Study of Colorectal Procedures With the Levita Magnetic Surgical System

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in colorectal procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is scheduled to undergo elective colorectal surgery

Exclusion Criteria:

* Significant comorbidities
* Subjects with pacemakers, defibrillators, or other electromedical implants
* Subjects with ferromagnetic implants
* Clinical history of impaired coagulation
* Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
* Subject is not likely to comply with the follow-up evaluation schedule
* Subject is participating in another clinical trial