cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.


Eligibility Criteria:
Inclusion Criteria:

In the case group:

* A history of solid brain tumor or haematological histologically proven.
* Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
* Radiotherapy treatment on a tumor in place or operated.
* Decline at least 10 years from the end of radiotherapy.
* Treatment with isocentric conformal radiotherapy.
* No other radiation therapy for locally recurrent brain metastases or new brain tumor.
* Lack of known brain metastases or meningeal carcinomatosis.

For the control group:

* Patients previously treated for cancer and disease relapse free for 10 years.
* No brain radiotherapy treatment.
* Lack of treatment with anti-cancer chemotherapy.
* Women of childbearing potential must be under effective contraception.
* Pairing according to age, sex, arms director and socio-cultural level.

For two groups:

* Man or woman aged (e) of minimum 18 years.
* Topic fluent French and comprising well.
* Free and Informed Consent signed.
* The subject should be affiliated to an appropriate social security system
* No cons-indication to MRI.
* The subject must have at least one primary school level

Exclusion Criteria:

In the case group:

* Brain radiotherapy carried out by intensity modulation technique.
* Radiation dose less than 36 Gy on the brain.
* Subject with against-indication to MRI.

For the control group:

* Previous history of brain radiotherapy.
* Previous history of brain surgery.
* Central neurological disorders, such as seizures, uncontrolled.

For two groups:

* Current Topics in oral chemotherapy or intravenous.
* Subject pregnant.
* Subject is not fluent in French or including bad.
* Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
* Participation in a therapeutic trial for less than 30 days.
* A person not affiliated with a social security scheme.
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma

This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.

One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12 weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 and \<75 years of age at the time of consent
* Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines
* Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening
* Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening
* Pre-bronchodilator FEV1 ≥40% and \<80% of predicted at Screening and Baseline
* AEC ≥0.30 x10\^9/L at the Screening visit
* ACQ-7 ≥1.5 at Screening
* Negative pregnancy test at Baseline
* Adherence ≥85% with twice-daily placebo taken during the Run-in Period

Exclusion Criteria:

* Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit
* Treatment with systemic corticosteroids in the 8 weeks prior to Screening
* Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline
* Treatment with selected drugs known to have a substantial risk of neutropenia
* Absolute neutrophil count \<2.0x10\^9/L at Screening, or any documented history of absolute neutrophil count \<2.0x10\^9/L.
* Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 at Screening
* Clinically significant abnormal laboratory or ECG values
* Other medically significant illness
* Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening
* Pregnant women or women breastfeeding
* Currently taking pramipexole or other dopamine agonists
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.

Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.

Eligibility Criteria:
Inclusion Criteria:

1. Age 3 to 18 years on day of surgery
2. diagnosis of spinal deformity
3. undergoing elective posterior spine multi-level instrumentation surgery

Exclusion Criteria:

1. Documented renal failure
2. documented allergy to iodine or shellfish
3. previous spine fusion surgery
4. undergoing elective posterior spine single-level instrumentation surgery
5. undergoing anterior spine multi-level instrumentation surgery
6. current antibiotic use.
Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity

Obesity is defined as abnormal or excessive fat accumulation. It is a complex disease with multifactorial etiology. Although the prevalence of obesity is generally greater in elders and women, obesity rates have increased in all ages and both sexes in recent years. Obesity or overweight also has a higher risk of diabetes, metabolic syndrome, dyslipidemia, hypertension, hyperuricemia, gout, osteoarthritis, cardiovascular disease, coronary artery disease, breast cancer, endometrial cancer and colorectal cancer. The body mass index (BMI), calculated as weight in kilograms divided by the square of height in meters, is widely used to define overweight and obesity in clinical studies. In Taiwan, subjects with BMI between 24 and 27 were diagnosed of overweight, and those with BMI over 27 were diagnosed of obesity.

Chinese herbal medicine (CHM) was widely used in the treatment of obesity. The main purpose of CHM treatment is to promote metabolism, suppress appetite and block intestinal digestion and absorption of fat. Since there are various adverse effects of anti-obesity medicines, and there are surgical complications including infection and anastomotic stenosis, patients may seek CHM for losing weight. Many studies have indicated the efficacy of single herb in the treatment of obesity.

Currently, the amount of computerized clinical data is increasing rapidly with the adoption of electronic medical records. The study is expected to collect the medical records, including the data of body weight, related side effects and biochemical data of each individual. By comparing the change of related data before and after CHM treatment, we could evaluate the efficacy of CHM in patients with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of obesity (ICD-9: 278.00) and received Chinese herbal treatment for obesity in outpatient clinic during January 1, 2007 and December 31, 2019.

Exclusion Criteria:

* Patients who were pregnant or breast feeding during treatment period.
* Patients who were diagnosed of hopothyroidism or Cushing's disease.
Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy

The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic sleeve gastrectomy

  * ASAA I or grade;

    * volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI\> 30kg / m2.

Exclusion Criteria:

* chronic pain;
* severe liver dysfunction (total bilirubin 2 mg dl-1);
* severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
* pregnancy or lactation;
* preoperative heart rate \<50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.);
* history of alcohol or drug abuse
Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

The purpose of this study is to investigate if a new blood test looking at PSA and a group of PSA related proteins in a patient's blood can indicate which men after surgery with a rising PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence before initial treatment is given.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with radical prostatectomy that develop a rising serum PSA ≥ 0.05ng/ml and have not received any kind of additional therapy.
* Patients who have had additional therapy post radical prostatectomy are eligible for this study if ≥1 year has passed since treatment and the patient develops a rising serum PSA ≥0.05ng/ml.

Exclusion Criteria:

* Previous additional therapy for prostate cancer, less than 1 year ago
* No evidence of rising PSA
* Patients unwilling to undergo venesection
Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children

The acute gastroenteritis is a very common problem in children. The frequency and duration of this condition involves a high discomfort for the child and his family, and significant costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use and hospitalization.

To limit vomiting and facilitate oral rehydration have been proposed several pharmacological strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side effects (ondansetron and metoclopramide) and therefore contraindicated in patients of pediatric age.

The administration of some medicinal herbs is able to induce an effective anti-emetic power. Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known as ginger is used as an antiemetic in various traditional systems of medicine for over 2000 years. There are several scientific evidence on the beneficial properties of ginger, including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and in pregnant. A recent meta-analysis has confirmed that ginger is effective in non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.

To date there are several formulations of the ginger on the market in Italy, and their use is fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the absence of clinical evidence of efficacy.

The purpose of the proposed study is to demonstrate the effectiveness of treatment with ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.


Eligibility Criteria:
Inclusion Criteria:

* Children, both sexes, aged 1-10 years,
* Diagnosis of acute gastroenteritis (duration less than 24 hours they had at least one episode of vomiting (no bile, no blood) in the previous four hours, with mild-state of dehydration moderate).

Exclusion Criteria:

* Children under 12 months of age and older than 10 years,
* concomitant presence of chronic diseases,
* malnutrition (z score for lower 3 standard deviations weight / height),
* severe dehydration,
* malformations of the gastrointestinal tract,
* malignancy,
* neurological diseases,
* metabolic diseases,
* eosinophilic esophagitis or other gastrointestinal diseases,
* history of functional dyspepsia or cyclic vomiting,
* history of abdominal surgery,
* history of food allergy ginger,
* renal failure and/or hypoalbuminemia
Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Endoscopic Skull Base Surgery

Skull base surgeries performed in areas involving the visual pathway are associated with varying levels of postoperative visual dysfunction. The goal of intraoperative FVEP monitoring is to detect and prevent intraoperative visual pathway injury.

Skull base surgeries performed in areas involving the visual pathway are associated with varying levels of postoperative visual dysfunction. For instance, surgical resection of suprasellar meningiomas has been shown to worsen visual function in 14 - 28% of patients and surgical resection of craniopharyngiomas worsen visual function in 3 - 11.5% of patients. Manipulation of the optic nerve and interference with the microvasculature during surgical dissection is thought to be responsible for the visual loss.

Through intraoperative monitoring and prompt identification of flash visual evoked potentials (FVEPs) deterioration, corrective surgical measures could be undertaken to improve or stabilize postoperative visual dysfunction. Furthermore, intraoperative FVEPs monitoring may influence surgical decision-making thus contributing to predict and prevent postoperative visual dysfunction as well as allowing more total resection of a tumour when the monitoring is stable.

This study's aim is to determine if intraoperative continuous FVEPs monitoring can predict and prevent or minimize possible visual pathway injury that may appear during minimally invasive endoscopic skull base surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult population (18 years and older), admitted to The Ottawa Hospital (TOH)-Civic Campus for a chiasmal or pre-chiasmal lesion, undergoing first time minimally invasive endoscopic skull base surgery
* Patient able to personally sign and date the informed consent document
* Patients will be selected based on the surgeon's determination that:

  1. The visual system will be at risk of iatrogenic injury
  2. The intraoperative FVEPs monitoring could rapidly detect this injury AND
  3. Corrective measures could be taken during surgery to reverse it.

Exclusion Criteria:

* patients having a pre-existent retinal disease, cardiac pacemaker
* contraindication for total intravenous anaesthesia (TIVA)
* unable to complete required pre and post-operative visual assessment or unable to complete their post-operative follow-up visits at TOH-Civic Campus
* anticipated goggle movement related to reflection of the frontal skin flap
* preoperative visual deficits (e.g., profound deficits in visual acuity or dense visual field loss)
SOLX Gold Shunt for Refractory Glaucoma

To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.


Eligibility Criteria:
Inclusion Criteria:

* primary open-angle glaucoma
* age 21 or over
* refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery
* detectable visual field defect (negative MD score)
* written informed consent
* available for up to 24 months follow-up

Exclusion Criteria:

* either eye with VA worse than count fingers
* angle closure glaucoma episode within past 12 months
* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
* diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
* other significant ocular disease, except cataract
* active ocular infection
* expected ocular surgery in next 12 months
* no suitable quadrant for implant
* systemic corticosteroid therapy \> 5 mg/day prednisone
* intolerance to gonioscopy or other eye exams
* mental impairment interfering with consent or compliance
* pregnancy
* known sensitivity to anticipated medications used at surgery
* significant co-morbid disease
* concurrent enrollment in another drug or device study
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. Subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11 and FX2016-12 - NCT03142451). Subjects must demonstrate that they are eligible to continue into Study FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the previous double-blind studies.

At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of active FMX103 1.5% minocycline foam.

Eligibility Criteria:
Inclusion Criteria:

1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.
2. Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12.

Exclusion Criteria:

1. Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results.
2. Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2329 are eligible
* Written informed consent
* HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2329
* Other protocol-defined exclusion criteria may apply