cyrilzakka/clinical-trials huggingface dataset:
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
* Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
* Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
* HbA1c (glycosylated haemoglobin) maximum 11%

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Previous participation in this trial. Participation is defined as randomisation
* Girls who are pregnant, breastfeeding or intend to become pregnant
* Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
* Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
* More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
* Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
* The receipt of any investigational drug within 1 month prior to Visit 1
Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy

The purpose of this study is to investigate the effect of electric stimulation on the pelvic floor function in cervical cancer patients with type III hysterectomy.

This is a prospective, multi center, open, randomized, controlled clinical trial. All cervical carcinoma patients who undergo type III hysterectomy in the hospitals involved in this study were recruited. 5-7 days postoperative, those who meet the inclusion criteria and without the exclusion criteria and sign the consent were randomized grouped of intervention and control objective by 1:1. At the same time, according to the research hospital, menopausal status (menopause vs menopause) and surgery approach (laparoscopic vs open)，they were further stratified randomly. Patients in the intervention group received electrical stimulation treatment based on conventional clinical nursing, while patients in control group only receive routine clinical care. Except for the treatment of electrical stimulation, other research procedures is the same in the two groups. The recovery rate of urination function, pelvic floor function and life quality of the two group is compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as cervical squamous cell carcinoma on Ⅰa2, Ib1 or Ⅱa1 stage
* Type III hysterectomy
* There are pathological results showing that cancer resection clean and no distant metastasis,Specifically as follows:Lymph nodes(-);cancer foci invasion depth \<1/2;Lymphatic space(-);Vaginal stump(-);differentiation G1-2.
* Patients agreed to the study, informed consent

Exclusion Criteria:

* Radiotherapy and chemotherapy before surgery
* Reserved nerve in the surgery
* Urinary system damage
* POP(Pelvic Organ Prolapse stage)\>II stage before surgery
* Moderate above stress urinary incontinence(SUI) before surgery(1 hours urine pad test\>=10g)
* Urinary retention before surgery
* Severe constipation or difficult defecation before surgery
* There are uncontrolled epilepsy, central nervous system disease or mental disorder history in patients.The clinical severity of these diseases Influence clinical research compliance,judging by the researcher.
Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland

The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced rectal cancer
* Local recurrence for colorectal cancer
* Curative treatment for colorectal cancer

Exclusion Criteria:

-
Stroboscopic Vision Training in Softball

Enhanced sports performance, in our current world, is being pushed at the professional level and down to school-age children as well. Money is being spent on lessons and equipment to enhance performance. One new method to enhance performance is stroboscopic vision goggles. The glasses lenses flicker removing visual information for a brief moment. The claim is that they train connections between the eyes, brain, and body. We want to see if this product truly does enhance visual performance during a softball season for high school girls.

In today's sports world, every strategy to perform at the highest level is needed. Current literature is demonstrating enhanced sports performance using stroboscopic vision training.1,2,5 The objective of this randomized controlled trial is to measure the effect of a stroboscopic visual training in a high school softball season in comparison to controls. Athletes in the control group will go through normal practice drills for hitting and fielding. The stroboscopic training (experimental group) will use the strobe glasses during hitting and fielding drills two times a week in practice. The brand of strobe glasses is Senaptec Strobe. Athletes in both the experimental and control groups will have their vision assessed at the beginning of the season and end by The West Texas Vision Center. Measurements for vision will include developmental eye movement, vergence ranges, Randot stereopsis test, accommodative ranges, acuity, and stereo scores. On-field performance measurements will be collected for batting statistics including on-base percentage, batting average, slugging percentage, and hard-hit ball percentage in both the experimental and control groups. The current year batting statistics will be compared with the prior year statistics if enough at-bats occurred. In addition, to the vision and on-field hitting performance proprioception balance using the Balance Error Scoring System (BESS) will be measured at the beginning of the season and end for both groups. Our data will provide quantified information for coaches, athletes, and health care providers concerning the benefits of the strobe glasses warrant buying to enhance sports performance. Additionally, we wish to determine whether visual-motor and proprioception balance changes occur after the training.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age 14-18 years 2) females; 3) high school softball

Exclusion Criteria:

* 1) Prior use of stroboscopic vision training; 2) History of seizures; 3) History of vestibular impairments
Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Implantable Cardioverter Defibrillator
* congestive heart failure
* informed consent

Exclusion Criteria:

* Non-MRI-compatible implants
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of prostate
* Metastatic disease
* Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
* Treatment with radiotherapy within 2 weeks before randomization
* Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
* Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
* Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
* A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
* Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
* Inability to swallow oral medications
A Single-Dose, Pharmacokinetic/Pharmacodynamic (PK/PD), & Safety Study of BIIB017 in Participants With Renal Impairment & Healthy Volunteers

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with renal impairment and in participants with normal renal function (healthy participants). A secondary objective of this study in this study population is to evaluate the safety and tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.

This study is an open-label, multicenter, non-randomized, serial-group study to estimate the effect of renal impairment on BIIB017 PK/PD. The study will be conducted at approximately 3 sites in the US and will enroll approximately 35 participants: 6 healthy volunteers (normal renal function), 9 with mild renal impairment, 6 with moderate renal impairment, 8 with severe renal impairment, and 6 participants with end stage renal disease who require hemodialysis 2 to 3 times a week.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must have stable renal disease (i.e., no change in disease status within the last month) as determined by the Investigator with laboratory and clinical findings that support the diagnosis of renal impairment.
* Must have body mass index (BMI) between 18 and 35 kg/m2 inclusive.

Key Exclusion Criteria:

* History of any clinically unstable (in the past 6 months prior to screening) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, and psychiatric, or other major disease as determined by the Investigator.
* Any evidence of clinically significant findings on screening evaluations, which, in the opinion of the Investigator would pose a safety risk, or would interfere with appropriate interpretation of safety or PK data, or other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment

NOTE: Other protocol defined Inclusion/Exclusion Criteria May Apply
The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease

This study aims to compare the outcomes of patients with long segment Hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to August 31, 2019
* Long-segment Hirschsprung disease (type A and B)
* Total colonic aganglionosis (TCA)
* Surgery at CHUSJ
* Tissue blocks of proximal resection margin available for pathological analysis
* Minimum 1 month of postoperative follow-up

Exclusion Criteria:

* Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)
* Total colonic with small bowel aganglionosis (TCSA)
* Surgery done at another institution
* Early deaths
* Lost to follow-up
* No documented post-operative outcome
Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
2. Willing and able to provide written informed consent for participation in the study
3. Willing and able to comply with scheduled visits and other study procedures.
4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Contraindication for a presbyopia correcting IOL.
2. Subjects with severe astigmatism in the non-dominant eye
3. Uncontrolled diabetes.
4. Use of any systemic or topical drug known to interfere with visual performance.
5. Contact lens use during the active treatment portion of the trial.
6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
7. Clinically significant corneal dystrophy
8. History of chronic intraocular inflammation.
9. History of retinal detachment.
10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
11. Previous intraocular surgery.
12. Previous refractive surgery.
13. Previous keratoplasty
14. Severe dry eye
15. Pupil abnormalities
16. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
18. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
19. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Prevention of Persistent Opioid Use in Mothers

Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.

A small percent of the large population of women who give birth have difficulty with prolonged pain, opioid use and poor functional recovery. This may be the first opiate exposure and significant health challenge in a young woman's life.

In our previous work, we have identified 20% who are at highest risk for prolonged pain and delayed opioid cessation and functional recovery with usual care. Moderate to severe pain on postpartum day 1 is a significant predictor of being in the risk group. The optimal intervention to mitigate this risk is unknown.

We plan to test an intervention of low dose gabapentin or placebo to be escalated by a pain medicine doctor as needed. We hypothesize that additional care of women predicted to be higher need by virtue of their postoperative day one pain score (\> 6 x2) despite usual multimodal analgesic care will lead to reduced need for opioid, less pain and more rapid functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* Delivery within 5 days, able to provide informed consent, English speaker

Exclusion Criteria:

* Opiate use disorder
A Prospective Cohort Study Of Myasthenia Gravis

The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed.

This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnosis of myasthenia gravis

Exclusion Criteria:

* Malignant tumor or other serious chronic disease
A Study to Improve the FAST Ultrasound Exam

This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.


Eligibility Criteria:
Inclusion Criteria:

* All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma.

Exclusion Criteria:

* Pregnant females
* Prisoners
* Patients with prohibitive right sided chest trauma
* Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination
* Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed
Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning

This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Invasive Mechanical Ventilation \> 24 hours.
* Readiness for weaning (following clinician decision made according to recent guidelines).

Exclusion Criteria:

* Impossibility to perform an echography.
Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to carbapenems by producing enzymes that break down carbapenems. The prevalence of CRE continues to rise globally but the treatment options are extremely limited. In case series, isolation of CRE from any site, whether there is clinical infection or not, has been associated with all-cause hospital mortality ranging from 29% to 52%. There are no known methods for reliably decolonizing gastrointestinal (GI) CRE. In rare case reports, fecal microbiota transplant (FMT) has successfully eradicated gastrointestinal colonization of CRE, but there has been no larger study further investigating this. FMT via oral capsules is the least invasive method and has demonstrated efficacy and short-term safety in treating patients with recurrent Clostridium difficile infections. Therefore, the investigators propose this pilot study to determine the effectiveness of oral capsule fecal transplantation in the decolonization of gastrointestinal CRE.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Have intestinal carriage of CRE

Exclusion Criteria:

* Pregnant
* Peripheral WBC \>12 x 10\^9/L and/or temperature \>38 degrees Celsius
* Swallowing dysfunction or known chronic aspiration
* Delayed gastric emptying
* History of intestinal obstruction
* Active CRE infection
* Acute exacerbation of underlying comorbid condition
* Severely immunocompromised patients
* Inflammatory bowel disease
* Allergies to ingredients Generally Recognized as Safe
* Adverse event attributable to previous FMT
* Concomitant antibiotic use or antibiotic use 48 hours before FMT