cyrilzakka/clinical-trials huggingface dataset:
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are:

1. What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX?
2. Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤85 years
* ECOG Performance status 0-1
* Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
* The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
* Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
* The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
* No evidence of distant metastases
* No prior pelvic radiation therapy
* No prior chemotherapy or surgery for rectal cancer
* No active infections requiring systemic antibiotic treatment
* ANC \&amp;amp;gt; 1.5 cells/mm3, HGB \&amp;amp;gt; 10.0 g/dL, PLT \&amp;amp;gt; 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
* Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

* Recurrent rectal cancer
* Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
* Creatinine level greater than 1.5 times the upper limit of normal
* Patients who have received prior pelvic radiotherapy
* Patients who are unable to undergo an MRI
* Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS \&amp;amp;gt;5 years
* Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
* Other anticancer or experimental therapy
* Women who are pregnant or breast-feeding
* Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.

Patients diagnosed with anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive steroid plus therapy （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and spinal cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） and anti-aquaporin 4 antibody et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who become positive for anti-aquaporin 4 antibody or have becomed.
2. Patients who have developed myelitis.
3. Patients who run beyond greater than 30 days at least from last time in relapse.
4. Patients who new neurological symptom or worsening neurological symptom or flared neurological symptom have sustained 24 hours at least not associated fever or infection.
5. Patients who have an acute exacerbation at informed consent.
6. Patients who need steroid plus therapy（1g/day for five consecutive days）.
7. Patients who can start steroid plus therapy within 3 days after informed consent.
8. Patients who be inadequate to effect to steroid plus therapy.
9. Patients with greater than or equal to twenty years old at informed consent.

Exclusion Criteria:

1. Patients who have developed optic neuritis.
2. Patients treated with intravenous immunoglobulin within 14 days before informed consent.
3. Patients with malignancy at informed consent.
4. Patients with history of shock or hypersensitivity for NPB-01.
5. Patients with IgA deficiency.
6. Patients with impaired liver function.
7. Patients with impaired renal function.
8. Patients with cerebro- or cardiovascular disorders.
9. Patients with high risk of thromboembolism.
10. Patients with hemolytic/hemorrhagic anemia.
11. Patients with decreased cardiac function.
12. Patients with decreased platelet.
Uncomplicated Nausea and Vomiting in the Emergency Department

Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.

This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department

Exclusion Criteria:

* Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
* gastrointestinal hemorrhage, mechanical obstruction or perforation
* patients with pheochromocytoma
* seizure disorder
* patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
* patients experiencing hyperemesis gravidum
* patients unable to understand the informed consent (intoxicated, Spanish speaking)
* prior antiemetics within 12 hours
* inability to perform visual analog scale
* renal dialysis
Pituitary Gland Stimulation for Cancer Pain Relief

Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* In palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy
* Inadequately controlled pain with standard care
* Most prominent part of experienced pain is nociceptive
* Karnofsky Performance Score ≥30

Exclusion Criteria:

* Not fit for general anesthesia
* Pregnancy
* Unfavorable local anatomy for PGS, due to a disease process, or anatomical configuration
* Clinical signs of posterior pituitary gland disfunction
* Recent history of alcohol or drug abuse
* Severe immunodeficiency
* Need for anticoagulation therapy that cannot be abrogated for surgery
* Need for subsequent MRI-imaging
* Cognitive impairments prohibiting full understanding of study and ability to provide informed consent
* Not able to adequately communicate in Dutch or English
Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the foot in a cast, to using a cast alone. The study will also examine how foot strength, joint movement, and overall ability to walk, balance and climb stairs is affected.

Patients with diabetes mellitus (DM) and peripheral neuropathy are at high risk for forefoot plantar ulcers and subsequent lower extremity amputation. Total contact casting currently is the most effective treatment for healing neuropathic plantar ulcers but ulcer recurrence is high (30-50%) when patients discontinue casting and resume walking. An equinus deformity (limited ankle dorsiflexion range-of-motion) is associated with these recurrent ulcers. Although descriptive evidence indicates an Achilles lengthening procedure (which corrects the equinus deformity) can improve healing rates in these chronic ulcers, there have been no controlled studies.

This randomized prospective controlled clinical trial will determine if percutaneous Achilles lengthening and total contact casting is more effective than total contact casting alone in healing forefoot plantar ulcers (n=30/group will allow detection of 25% effect with power of 0.8 at alpha level of 0.05). Secondary purposes are to determine the effects of casting and percutaneous lengthening on measures of impairments, functional limitations, and disability in patients with DM and peripheral neuropathy. The specific aims of this project are to determine the effect of the Achilles lengthening procedure on patients with DM, peripheral neuropathy, a forefoot ulcer, and an equinus deformity in regards to 1) Wound healing, 2) Impairments (dorsiflexion range-of-motion, plantar flexor muscle performance), 3) Functional Limitations (Physical Performance Test, Functional Reach, walking ability), and 4) Disability (SF36). The results will have important implications for prevention of wound infection and lower extremity amputation; and improvement in impairments, functional limitations, and disability in this group of high risk patients with chronic disease. Approximately 30 patients will be recruited for each of the treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* History of Diabetes Mellitus
* Limitation of dorsiflexion ankle range of motion to zero degrees or less
* Recurrent or nonhealing ulcer (Grade II, Wagner scale)

Exclusion Criteria:

* Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure.
* Patients with a history of CVA or other significant neurological problems complicating their rehabilitation.
* Patients with a history of midfoot or hindfoot Charcot fractures.
* Patients with an Ankle-Arm index \< 0.45 or absolute toe pressure \< 40 mm Hg.
* Patients medically unfit for the anesthesia required for this Achilles lengthening procedure.
Assessment of Longterm Ureteral Stenting

This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.

The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting.

In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.

The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
* Informed consent
* responsible patients

Exclusion Criteria:

* ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
* insufficient language skills
* cognitive limitation
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
* IOP of 22mmHg or higher obtained during the pre-study period.
* Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:

  1. 3 weeks for B-adrenergic antagonists
  2. 2 weeks for adrenergic agonists
  3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

* History of acute angle closure.
* Severe trauma at any time.
* Intraocular surgery or argon laser trabeculoplasty within 6 months.
* Current use of contact lenses.
* History of severe dry eye syndrome.
* Ocular inflammation/infection with three months of inclusion.
* Any condition preventing reliable applanation tonometry.
* Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
* In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
* Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
* Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
* Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Having participated in any other clinical study within the last month.
Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery

Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.

OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.

METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* lower abdominal surgery

Exclusion Criteria:

* Consumption antagonists adrenergic or channel blockers Ca ++
* Patients with arrhythmias or heart block
* Allergic to any drugs under study
* Obese
* Physical or mental incapacity to understand and use the pain scale
* Contraindication for anesthesia conductive
* Realization difficulty or complication during anesthesia and / or surgery
VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax

This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.

Traumatic injuries are a significant cause of morbidity and mortality in our society.At Assiut university hospitals, chest injuries (17.7%) considered as second cause of mortality after head injuries (34.6%) of registered deaths by cause of injury at trauma unit, Assiut university hospitals in a study conducted between,2002-2009. In United States, thoracic injuries are the primary factor in approximately 35% of these deaths, one -third of which occur immediately following the injury, and are contributing in nearly 75% of trauma -related deaths. Up to 15% of patients who sustain thoracic trauma undergo emergent thoracotomy for resuscitation, massive hemothorax, cardiac tamponade, large thoracic wounds, major thoracic vascular injuries, tracheobronchial injuries, or evidence of esophageal injury. The remaining 85-90% of patients who reach the emergency department does not require emergent thoracotomy are initially managed with tube thoracostomy, pain control, pulmonary toilet, and observation .Patients failing this management ultimately require elective thoracotomy for further evaluation and treatment(clotted hemothorax, empyema and diaphragmatic hernia. The current role of VATS in trauma includes evaluation and control of continued chest tube bleeding, early evacuation of retained hemothorax, evacuation and decortication of posttraumatic empyemas, evaluation and limited treatment of suspected diaphragm injuries, evaluation and treatment of persistent air leaks, and evaluation of mediastinal injuries.

Eligibility Criteria:
Inclusion Criteria:

We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:

1. Ages that are eligible for study are between 18years to 60 years (adult)
2. Both genders will be included to study.
3. Clinical and radiological diagnosis of persistent haemothorax.
4. Thoracostomy tube blockage or failure to drain within 5-7days.

Exclusion Criteria:

1. More than one thoracostomy tube drainage in the same attempt side.
2. Unable to consent to trial.
3. Coexisting pathology requiring other interventions.
4. Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).
Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)

Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD.

Although the therapeutic methods progress, numerous patients with Chronic Kidney Disease (CKD) can not avoid the clinical outcome of end-stage renal disease. CKD still needs novel treatment to significantly improve the survival quality of the patients.

Gut microbiota has been verified to have relation with immunity. Immunity plays a role in many chronic kidney disease, such as IgA nephropathy, membranous nephropathy and so on. Fecal microbiota transplantation (FMT) is a novel, safe, convenient therapeutic treatment which transplant gut microbiota from donor to patient to rebuild a gut microecology.

This study aims to evaluate the efficacy and safety of FMT in CKD patients. Patients in this study will undergo three times WMT. The primary outcome measure was the clinical remission efficacy rate in the CKD patients. The secondary outcome measure was the safety of WMT in CKD.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with chronic kidney disease without WMT in the past three months
* Able to tolerate colonoscopy
* Receiving rescue FMT from the China Microbiota Transplantation System
* Suitable and compatible with WMT treatment
* Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form
* Able to receive follow-up examinations, follow-up examinations and retain specimens on time

Exclusion Criteria:

* Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT
* Antibiotics or probiotics within 4 weeks prior to enrollment
* Patients with anxiety, depression, mental or legal disabilities
* Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy
* Other patients deemed unsuitable for enrollment by the investigator
Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

Based on the KD research group network established during the first survey in Shanghai, a set of questionnaires and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. Medical records of participants with KD diagnosed from January 2013 through December 2017 will be retrospectively analyzed. Data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings.

Age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. Univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.

Eligibility Criteria:
Inclusion Criteria:

- meeting the diagnostic criteria for Kawasaki disease released by American Heart Association 2017

Exclusion Criteria:

* not in acute phase;
* repeated cases;
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab

Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
* Participants who self-identify as Black or African American or Hispanic/Latino American
* Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
* Neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion Criteria:

* Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
* Primary Progressive Multiple Sclerosis (PPMS)
* Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
* Infection Related
* Cancer Related
* Pregnant or lactating, or intending to become pregnant during the study
* Other Medical Conditions
* Known presence or history of other neurologic disorders
* Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
* Laboratory: abnormalities or findings at screening