cyrilzakka/clinical-trials huggingface dataset:
Intracranial Hypertension and Optic Nerve Sheath Diameter

Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP) monitoring is likely to guide therapeutics, and certain research on adults or on children, suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve the prognosis. Two monitoring techniques are currently recommended. They are reference methods for ICP measure :

* monitoring with intraventricular catheter,
* intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD) which is the most interesting one. The ONSD measured ultrasonically is correlated with ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the first 24 hours. In children, ONSD average values have been worked out, and an ONSD increase is found in children suffering from hydrocephalus with IH and in children with TBI. ICH precocious detection is fundamental in children sensitive to ICH because their cerebral development is not finished yet. Difficulties met for ICP monitoring implementation in infants and its invasive nature are often disliked by clinicians. A non-invasive exam is then essential to allow a better care of children with ICH in intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

For the 97 patients:

* children from 2 months to 16 years
* in the intensive care unit
* TBI : moderate (GCS between 9 and 12) to severe (GCS \<9), whatever the mechanism involved
* informed consent form signed by parents

Non inclusion Criteria:

* obesity (BMI \> 97th percentile for the age)
* patient already under replacement therapy.
* patient taking AEDs
* patient with long-term systemic corticosteroid therapy
* history of neurological disease or learning difficulties
* no covered by a national health insurance
Trail-running After Knee or Hip Arthroplasty

The incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy.

In younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management.

The repercussions of returning to sports after arthroplasty have been widely studied in the literature.

Few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.

The incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy. Projections predict an increase in the number of prosthetic surgeries between 2020 and 2030 of 150% for total hip replacements (THR) and 230% for total knee replacements (TKR).

In younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management. They are also more likely to resume physical activities with high peak joint stresses, known as "high-impact sports", most often against the advice of their surgeon.

The repercussions of returning to sports after arthroplasty have been widely studied in the literature. These are essentially descriptive cross-sectional studies which show greater participation in low or medium impact sports activities in patients with prostheses.

Few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.

Concerning trail running, a discipline in full expansion, particularly in the longest formats; a single study in 2019, involving 18 runners with a prosthesis, did not reveal any specific constraints compared to healthy runners during a 170 km ultratrail.

Eligibility Criteria:
Inclusion Criteria:

* Trail runner (declarative)
* Having been operated for a hip or knee arthroplasty
* No limit to the length of time or volume of trail riding

Exclusion Criteria:

* Refusal to participate
* Trailer not understanding French
Improving Parent Understanding of Instructions About Asthma Care

Asthma has an especially great impact on poor urban children and their families. In addition to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low health literacy. Low health literacy is associated with poorer asthma outcomes. The provision of a written asthma action plan has been shown to help with asthma management and to reduce hospitalizations and ER visits. Poor urban families who may have low literacy may need an alternative asthma action plan to convey the treatment plan.

This pilot study proposes to investigate whether a plain language asthma action plan can improve parent understanding and adherence with medication instructions, compared to standard written materials, among parents of children with asthma. This is an RCT in which parents of children with asthma will be randomized to either receive a pictogram-based low literacy asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive the low literacy plan have improved asthma action plan knowledge when presented with a hypothetical scenario.

A second part of the study is to examine whether providers who are given the pictogram-based low literacy asthma action plan will be more likely to counsel about certain aspects of asthma management (eg. need for daily medications even when sick, spacer use, confusion between everyday and rescue inhaler)compared to providers who receive use a standard action plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a hypothetical patient using the pictogram-based action plan or the standard action plan (AAAAI).


Eligibility Criteria:
Parent study:

Inclusion Criteria:

* Primary caregiver / parent / legal guardian of child 2-12 years old
* Child with diagnosis of asthma

Exclusion Criteria:

* Parent not English or Spanish-speaking

Provider study:

Inclusion Criteria:

* Health providers who care for children with asthma
Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.

Femur fractures are a common injury in the Pediatric population. Despite their high incidence little do we know about the long term implications on the bones' length. Our main goal is to clarify this obscure issue by assessing the femoral and tibial length as determined by the fractures, measuring techniques and treatment modalities


Eligibility Criteria:
Inclusion Criteria:

* Males between the ages 0-16.
* Females between the ages 0-14.
* Signed Informed consent

Exclusion Criteria:

* A refusal by the patient or his legal guardian to continue the follow-up with the
* Pediatric Orthopedic clinic, or to have the CT scanograms.
* Patients with severe contractures in the lower extremities
* Patients with multiple lower extremity fractures
* Pregnancy
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer

Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).

However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.

Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.

The investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients
* Diagnosed prostate cancer

Exclusion Criteria:

* Metastatic disease at presentation
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.

The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.

With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.

Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.

The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.

Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.

Eligibility Criteria:
Inclusion Criteria:

* RYGB operated patients with documented hypoglycemia (blood glucose \<3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)
* Hemoglobin \> 7,3 mmol/L
* Negative human chorionic gonadotropin (hCG) urine test
* Females of reproductive age: use of safe contraception

Exclusion Criteria:

* Treatment for cardiovascular disease
* Treatment with antipsychotic medication
* Treatment for thyroid disease
* Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
* Prior allergic reactions to the study medicine
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are:

* Dose FMT alleviate the symptom of severe rectal bleeding?
* Dose FMT improve the endoscopic findings of proctopathy?

Participants will:

* Take fecal microbiota capsules by 8 sessions over a 12-week period.
* Visit the clinic once every 4 weeks for checkups and tests.
* Keep a diary of their symptoms and the number of times they use other supportive care.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old
* At least 3 months since the completion of pelvic radiotherapy
* No evidence of tumor recurrence or metastasis
* Rectal bleeding with grade 2-4 by LENT-SOMA scales
* Colonoscopy indicating rectal congested mucosa or telangiectasia
* Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months

Exclusion Criteria:

* Acute or chronic infectious diseases
* Serious systemic diseases
* Known allergies to any components of the study medication
* Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
* Late complications related to pelvic radiation injury
* Other hemorrhagic or coagulation disorders
* Previous rectal resection
* Bowel obstruction or perforation that require surgery
* Cognitive or psychological disorder
* Contraindications to FMT administration
Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.

Eligibility Criteria:
Inclusion Criteria:

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral knee arthroplasty

Exclusion Criteria:

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. Using anticoagulant drugs within a week.
4. Coagulopathy (preoperative platelet count \<150,000/mm3,International Sensitivity Index（INR）\>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time \>1.4 times longer than normal.
5. Breastfeeding
6. Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate\<60); or hepatic disfunction(glutamic-pyruvic transaminase\>80 or glutamic oxalacetic transaminase\>80).Retinopathy (disturbances of color vision).

9.History of thromboembolic disease
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)

The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.

Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance

Exclusion Criteria:

* Patients scheduled to undergo revascularization at the time of enrollment
* Patients who are being treated with an oral hypoglycemic drug or an insulin preparation
* Patients with a history of laparotomy of ileus
* Pre- and postoperative patients or individuals with severe infection or serious trauma
* Patients with gastrointestinal disorders such as diarrhea and vomiting
* Patients with a history of hypersensitivity to acarbose
* Pregnant or possibly pregnant women
* Patients who are judged by the attending physician to be otherwise ineligible
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Eligibility Criteria:
Inclusion Criteria:

* male patients with LUTS associated with BPH diagnosed \> 3 months
* IPSS score \> 13
* voiding and storage symptoms
* maximum flow rate of \> 4 mL/s and \< 15 mL/s

Exclusion Criteria:

* post void residual volume \> 200 mL
* symptomatic urinary tract infection
Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy

Identification of musculoskeletal and neuromuscular factors that affect the integrity and functional performance in children with cerebral palsy is very essential as it enables multidisciplinary rehabilitation team to design the proper intervention to improve functional performance and independence for those children.

Limited literature is available regarding the relation between selective voluntary motor control and motor functions in children with cerebral palsy. Up to our knowledge this is the first study intending to investigate the influence of selective voluntary motor control on upper extremity function in children with spastic cerebral palsy. Therefore, the current study will be conducted to investigate the correlation between selective voluntary motor control and upper extremity functions in children with spastic hemiparetic cerebral palsy.

It is hypothesized that:-

1. There is no relation between SVMC and upper limb function in children with spastic hemiparetic CP.
2. There is no relation between upper extremity SVMC and hand grip strength in children with spastic hemiparetic CP.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 4 to 8 years.
* Both genders.
* Diagnosis of spastic hemiparetic cerebral palsy.
* Level I-IV on Manual Ability Classification System.
* Spasticity grade 1 to 2 on Modified Ashworth Scale.
* Level I-III on Gross Motor Classification System .

Exclusion Criteria:

* Significant mental or psychological problems.
* Significant visual/auditory problem.
* Botox injection and/or surgery of the upper limb in the past 12 months.
* Fixed deformities in the affected upper extremity.
MK0767 and Metformin Combination Study (0767-028)

A study to test the effects of MK0767 when added to Metformin in patients with inadequately controlled Type 2 Diabetes Mellitus.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* All women of childbearing potential must have a negative urine pregnancy test prior to starting the study
* Patients must be on a stable dose of metformin for at least 2 weeks prior to visit 2

Exclusion Criteria:

* Patients with a history of type 1 diabetes mellitus and/or history of ketoacidosis
* Patients on estrogen replacement therapy regimen or SERM
* Patients with history of, allergy to, intolerance or hypersensitivity to statins or fibric acid derivatives, including history of elevated muscle and liver function tests, jaundice, hepatoxicity, or myopathy associated with these treatments
* Patient is on a weight loss program with ongoing weight loss or starting an intensive exercise program within 4 weeks from starting the study
* Have active liver or gall bladder disease
* HIV positive
Characterization of Receptors in Non-functioning Pituitary Macroadenomas

Characterization of receptors present in non-functioning pituitary macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) would assist with targeted medical therapy based on the information obtained by immunohistochemistry and RT-PCR.

The pituitary gland in the brain is the master hormonal gland and is surrounded by important nerves and blood vessels. The pituitary gland can develop various types of tumors, some which do not produce any hormones and are called non-functioning pituitary adenomas. These non-functioning tumors can grow and can cause compression of these important structures. The usual treatment of large non-functioning pituitary macroadenoma is surgery. As it is surrounded by neuro-vascular bundles, this makes complete removal of the tumor sometimes impossible and even dangerous. A large number of subjects will still have some residual tumor post-surgery. The risks of residual tumor are further growth with compression and compromise of the function of surrounding vital organs especially vision.

If there is further growth of the tumor the options at present are repeat surgery or radiotherapy. Repeat surgery involves all the risks associated with brain surgery and sometimes may not be possible if very close to vital organs, while radiotherapy will over a period of time lead to complete or partial deficiency of pituitary hormone function and has been associated with long term cognitive deficits. In addition radiotherapy has a lag time of 12-24 months prior to onset of action.

However, pituitary tumors that do not actively secrete hormones may still harbour receptors to various hormones. The blockage of these receptors by various medications may enable us to stop the tumor from growing or recurring after surgery. This may open up a novel means of treatment of these non functioning tumors. So far there is very little information in the literature about the type of receptors present in these tumors.

Our study proposes to obtain a piece of the tissue removed during surgery and perform receptor characterization to help improve our knowledge in that area. Also correlating the receptor status with the clinical, hormonal and radiological profile of the patients may help to develop improved treatment strategies in the future and help us to predict the possibility of tumor regrowth.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, both males and females age 18 years old or more
2. Pituitary tumor more than 10 mm in diameter diagnosed by MRI
3. No clinical or laboratory evidence of pituitary hormone oversecretion (non-functioning pituitary macroadenoma)

Exclusion Criteria:

1. Subjects with pituitary tumors less than 10 mm in diameter
2. Subjects with clinical or laboratory evidence of hormone oversecretion
3. Presence of dementia