cyrilzakka/clinical-trials huggingface dataset:
Reconstructing Forked Corpus Spongiosum in Hypospadias Repair

Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. However, the surgical success rate of hypospadias is still not ideal. Although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. How to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists.

In the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (FCS) in hypospadias repair with urethral plate preservation. It has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. In order to promote the technology of reconstructing FCS, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. Therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing FCS in hypospadias repair.

In this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in Urology Department, Children's Hospital of Fudan University, Shanghai, China. Participants will be random grouped: Routine standardized surgery with reconstructing FCS group and Routine standardized surgery group. All participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, HOSE objective score of cosmetic outcome and voiding function. By collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of FCS; (2) the effect of reconstructing FCS on the complications of primary hypospadias repair; (3) the effect of reconstructing FCS on the cosmetic outcome; (4) the influence of reconstructing FCS on postoperative voiding function.

Based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing FCS in various types of hypospadias repair. The study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.


Eligibility Criteria:
Inclusion Criteria:

* children with primary hypospadias
* one-stage surgical repair

Exclusion Criteria:

* staged surgery repair
* micropenis
* reoperation for postoperative complications
* using testosterone or male hormones preoperatively
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit.

Exclusion Criteria:

* Patients \<10 kg
* Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure)
* Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities)
* Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated)
* Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).
Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Controlling Myopia Progression

Background: Myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. The number of myopia in China ranks first in the world. According to statistics from the National Health and Health Commission, the myopia rate of children and adolescents nationwide in 2020 will be as high as 52.7%. High myopia often leads to permanent visual impairment and even blindness. Retinopathy complicated by high myopia has become the first irreversible blinding eye disease in Shanghai and other regions. The problem is severe. Therefore, it is necessary to actively seek effective myopia treatment and correction methods to slow down the progression of myopia and the excessive extension of the eye axis and reduce the occurrence of complications.

Objective： On the basis of previous research, this study put forward the hypothesis that if behavior management (including outdoor light exposure and close-range eye-use behavior) can be strengthened in children with myopia wearing defocusing frame glasses, it is possible to achieve more effective myopia control effect, thereby not only ensuring safety also effectiveness. A randomized controlled clinical trial is conducted to evaluate the efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression in children and adolescents.

Intervention: Group 1 ( AI defocusing frame glasses group), Group 2 ( Ordinary defocusing frame glasses group). The study period will be 2 years and each participant will be followed up every six month.


Eligibility Criteria:
Inclusion Criteria:

* The cycloplegic refraction of two eyes is \[-0.50D, -5.0D) the astigmatism is ≥ -1.50D; or the cycloplegic refraction of either eye is \[-5.00, -10.00D), the astigmatism is ≥ -2.50D;
* Willingness to wear only trial-provided defocusing frame glasses during the trial
* Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
* Written informed consent of guardian and child.

Exclusion Criteria:

* Allergy or intolerance to cycloplegic drugs;
* The anisometropia is greater than 1.50D;
* Using atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc. for myopia treatment;
* Strabismus/Amblyopia;
* History of eye surgery (including strabismus correction);
* Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
* Corneal, conjunctival or eyelid damage or other diseases (keratoconus, herpes simplex keratitis, etc.);
* There are anatomical or skin factors that affect the wearing of spectacles;
* Other circumstances that the investigator judges inappropriate to participate in the trial.
Depression Screening in Primary Care: Using HIT for Patients With Limited English

This study assessed the potential of Health Information Technology (HIT) to improve the screening, diagnosis, and treatment of depression and post-traumatic stress among LEP Southeast Asians. Should this intervention be found to be effective, the principles of the HIT technology could be easily adapted for screening in other languages to increase the recognition and treatment of depression and PTSD in primary care settings.

The prevalence of depression in primary care is high. Primary care physicians serve as the initial point of contact for most patients with depression, yet it is estimated that only about half of the depressed patients who present for care are recognized and treated. Language barriers can further exacerbate this problem. Approximately 54 million people in the United States speak a language other than English at home and over 21 million are limited English-language proficient (LEP). Language barriers may result in less discussion about patients' mental health needs and fewer referrals to specialty mental health services. Recent advances in health information technology (HIT), however, may facilitate novel ways to screen for mental health problems among limited English proficient patients. The HIT intervention is a provider-level intervention that consists of four components: 1) web- based training for the providers; 2) multimedia electronic screening of patients for depression and PTSD; 3) immediate notification to the health care providers and integration with the patients' electronic health records (EHR); and 4) provider clinical decision support. In a randomized controlled trial in a primary care setting, we will assess the potential of a multi-component health information technology intervention to improve the screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder among LEP Southeast Asians. We will examine the usability and acceptability of this technology to patients with limited English skills and their providers. Finally, we will identify and evaluate potential facilitators and barriers to wide spread implementation and dissemination of the HIT intervention. This technology has the potential to be adapted and utilized for any group of limited English-language proficient (LEP) patients, regardless of their native language, and has the potential to be adapted for providers to aid in the recognition, diagnosis, and treatment of mental health problems in diverse primary care settings.

Eligibility Criteria:
Inclusion Criteria:

* Cambodian patients over age 18 were included.

Exclusion Criteria:

* Patients with severe visual/hearing impairments, major psychiatric disorders such as bipolar disorder or schizophrenia, and/or life-threatening illness, which limited their ability to consent to the study were excluded.
Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery

A double-blinded randomized control study using a pulsed electromagnetic field therapy to establish whether this device decreases patient pain and decreases narcotic use in women who have undergone cesarean delivery.

This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PEMF using the Ivivi SofPulse on postoperative pain severity and narcotic use in women after cesarean delivery at Jacobi Medical Center. On admission to labor and delivery or in the obstetrical outpatient office, potential subjects will complete questions related to inclusion / exclusion criteria and sign a consent to participate in the study. If eligible, patients will receive a Ivivi Sofpulse device which will be placed over the incisional area and turned on. The devices are randomized into functional and sham groups. The device will be left around the incision site unless the patient needs to shower. In an effort to minimize bias, the patients, providers and investigators will not be aware if the device is functional or not. Lot numbers will accompany the device. After completion of the study, the Lot numbers, which will be provided by the manufacturer, will reveal which devices were functional devices or shams. These lot numbers will only be provided on completion of the trial. Wong-Baker Faces pain assessment tool will be evaluated by the Principal Investigator (PI) or co-investigator for determination of subjective postoperative pain at 0, 2, 6, 12, 24, 48, and 72 hours after cesarean delivery. Amount of oxycodone in milligrams consumed by patients will be recorded 24, 48, 72 hours after cesarean delivery. Postoperative anesthesia type (Duramorph or morphine patient controlled anesthesia pump) will be recorded as well. Subjects will be randomized to PEMF treatment (functional), or sham treatment. All subjects will be followed for the duration of their stay in the hospital following their cesarean delivery.

No follow-up is required. The goal is to recruit one hundred patients over the course of four months. Patient data will be identified by use of medical record number and will be kept private on the Jacobi Medical Center Obstetrics and Gynecology server which is password protected. Access will only be for the investigator and co-investigators in the study. Nurse on labor and delivery have already received an in-service on the proper use of this device.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years
* Female
* Undergoing lower transverse cesarean delivery or cesarean delivery with bilateral tubal ligation.
* Pfannenstiel Skin incision
* Consent to the study and willing to comply with study methods

Exclusion Criteria:

* • Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)

  * Patients undergoing additional procedures at the time of their cesarean delivery such as cesarean hysterectomy or myomectomy.
  * Patients with vertical skin or uterine incisions.
  * Patients who forget to, or decide not to, replace PEMF device
Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16\~65 years.
* Serum HBsAg positive for over six months.
* Meet the diagnostic criteria of liver failure:

Exclusion Criteria:

* History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
* Prothrombin time is over 30s.
* Cirrhosis caused by other reasons except HBV infection.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Liver tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* Imaging evidences of vascular thromboses.
Neuromuscular Electrical Stimulation in the Critically Ill

Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of COPD (chronic obstructive pulmonary disease) patients (among others) to improve their resistance to efforts in everyday life. In patients in intensive care, it seems to improve strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days, with expected effects on the duration of hospitalization and the long-term functional outcome. Although its use could sometimes be limited by the development of peripheral edema and use of vasoconstrictors, the main advantage of this technique is the possibility of being used very early, even in patients that require deep sedation . This is extremely important given that the muscular atrophy process already starts 18h after the onset of invasive ventilation and as signs of impaired nerve transmission are developed in one third of patients at risk within 72 hours.

The purpose of the study is to assess the effects, in the short and medium term, of early neuromuscular stimulation in patients who are at higher risk of developing a critical illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.

This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.


Eligibility Criteria:
Inclusion Criteria:

* Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
* Aged over 18 years
* Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)\<200mmHg)
* SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.

Exclusion Criteria:

Definitive exclusion criteria:

* patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
* BMI superior to 35
* serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
* pregnant women
* patients admitted from Friday evening to Sunday morning

Temporary exclusion criteria:

* Hemodynamic instability (even with filling up and amines: noradrenaline \> 0.5y/kg/min and/or dobutamine \>5y/kg/min and/or adrenaline ivc)
* Extreme severity with suspicion of death within the first 24 h
* PIC \> 20 cmH2O
* Severe agitation (RASS \> +1)
* Curare utilisation within the last 24h
Prostate Reirradiation Toxicity Outcomes Feasibility Study

The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.

Radiotherapy is the most common curative treatment for non-metastatic prostate cancer, however up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy (EBRT), high intensity focused ultrasound and cryotherapy. Systematic review shows that high dose rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.

The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient reported outcome measures (PROMs) to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male individuals aged over 18 years
* Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)
* No metastatic disease
* Able and willing to provide an informed consent to participate
* World Health Organisation (WHO) performance status 0-2
* Reasonable urinary function (IPSS \< 20 and Qmax \> 10 ml/second on flow tests)
* Greater than 10 year life expectancy

Exclusion Criteria:

* Patients who are unfit for a general anaesthetic due to other comorbidities
* Clinical or radiological evidence of metastatic prostate disease
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
* Contraindication or intolerance of magnetic resonance scanning
* Prior prostatectomy
* History of inflammatory bowel disease.
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress.

The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial amputees in hospitalized in the rehabilitation of the musculoskeletal system service
* All etiologies: vascular, traumatic and septic.
* Adapted vascular equipment validated by physician.
* Able to walk for 5 minutes on a treadmill without technical assistance.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in an interventional study or one involving a drug or medical device, or is in a period of exclusion determined by a previous study
* Patient already included in the present study.
* The subject refuses to or is unable to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patients with uncorrected or untreated visual disorders.
* Patients with major cognitive disorders (MOCA\>23).
* Patients with vestibular disorders.
* Patient with uncontrolled epilepsy.
* Patient with an unhealed amputation stump.
* Patients weighing \> 135kg or \< 20kg.
* Patients with a functional ambulation category of 1 (i.e. patients requiring the firm, continuous assistance of another person to carry their weight and maintain their balance) or less.
* Patients with medication affecting exercise tolerance,
* Patients with sensory impairments
* Patients with significantly reduced bone density
* Patients for whom it is impossible to correctly adjust the harness to the corresponding body part due to:

  * Body shape
  * Colostomy bags
  * Skin lesions that cannot be adequately protected.
  * Any other reason that prevents proper, pain-free adjustment of the sling.
* Pregnant, parturient or breast-feeding patients.
* Appearance of a stump wound during the study requiring discharge.
* Patient with more than 50% absenteeism from rehabilitation sessions.
* Patient requiring a new prosthesis insert.
* Patient with a serious adverse event affecting dynamic balance rehabilitation.
Eating Disorders Genetics Initiative

The overarching intention of the Eating Disorder Genetics Initiative (EDGI) is to lay the foundation for all future genomic discovery in eating disorders--anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED)--by exploring both genetic and behavioral factors. To do this, information will be collected from 4000 people who have provided DNA samples for the Anorexia Nervosa Genetics Initiative (ANGI) and the same information and DNA will be collected from an additional 16,000 people. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.


Eligibility Criteria:
Inclusion Criteria:

* A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior
* Age 15-99 years

Exclusion Criteria:

* History of subthreshold disordered eating behaviors