cyrilzakka/clinical-trials huggingface dataset:
Preadmission Metformin Exposure and Incidence of Acute Kidney Injury

More than 50% of ICU patients suffer from Acute kidney injury (AKI). Metformin shows protective properties in kidney disease. Our study aimed to validate AKI incidence among diabetes patients in the ICU with or without preadmission metformin exposure. We included non-AKI patients with type 2 diabetes in Medical Information Mart for Intensive Care (MIMIC)-III database. Incidence of AKI and mortality were compared between those with and without preadmission prescriptions.

Emerged as a major public healthy problem, Acute kidney injury (AKI) is now influencing millions of people worldwide and leading to reduced survival, increased progression of latent chronic kidney disease (CKD), and even new onset of CKD. More than half of intensive care unit (ICU) patients underwent AKI in a recent multinational cross-sectional study, often resulting in the need for renal replacement therapy with a high socio-economic impact for the patients.The effective precaution and treatment strategy remains limited.

As the most general and first-line biguanide antihyperglycemic drug, metformin has anti-inflammatory characteristics and is related with decreased all-cause mortality compared with other antihyperglycemics.. In some clinical trials and experimental studies conducted on divergent rodent models representing various types of kidney diseases going from AKI to CKD, metformin has been shown beneficial effects on the kidney. Moreover, preadmission metformin exposure is associated with a lower rate of 28-day mortality among AKI patients showed in several clinical studies.

However, in critical care patients with type 2 diabetes, the evidence of preadmission metformin usage decreasing a risk of AKI incidence is still absented. Therefore we performed a retrospective cohort study to validate the association of preadmission metformin exposure and AKI incidence in patients with diabetes in the ICU .

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* \>16 years old and \<90 years old
* without AKI

Exclusion Criteria:

* CKD
* data error
* type 1 diabetes
* diabetes patients with pregnancy
* no metformin record
* with AKI
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery

The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.


Eligibility Criteria:
Inclusion Criteria:

- consecutive patients visiting the emergency department

Exclusion Criteria:

* admitted primarily for a psychiatric reason
* left without consultation
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India

This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.


Eligibility Criteria:
Inclusion Criteria:

* HCV-infected patients living in India
* Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.
* Patients who provide written and signed informed consent prior to initiation of treatment where required.

Exclusion Criteria:

* Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
* Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)
G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This clinical trial is studying how well a G-CSF-treated donor bone marrow transplant works in treating patients with hematologic cancer or noncancer.

OBJECTIVES:

Primary

* Determine whether granulocyte engraftment can be achieved by day 30 in patients with hematologic disorders undergoing HLA-matched, related-donor, allogeneic bone marrow transplantation using filgrastim (G-CSF)-primed bone marrow.
* Determine the incidence of grade II or greater acute graft-versus-host disease (GVHD) in patients treated with this regimen and post-transplantation immunosuppression with cyclosporine and methotrexate.

Secondary

* Determine whether platelet and red blood cell engraftment can be achieved in patients treated with this regimen.
* Determine the incidence of limited and extensive chronic GVHD in patients treated with this regimen.
* Determine the event-free survival of patients treated with this regimen.
* Determine the post-transplant immune reconstitution in patients treated with this regimen.

OUTLINE: This is a pilot study.

* Mobilization: Donors receive filgrastim (G-CSF) subcutaneously (SC) daily on days -3 to -1 followed by bone marrow collection.
* Conditioning regimen: Patients receive 1 of the following conditioning regimens according to their primary disease:

  * Total-body irradiation and high-dose chemotherapy comprising etoposide and cyclophosphamide
  * High-dose chemotherapy comprising busulfan and cyclophosphamide
* Bone marrow transplantation: Patients receive G-CSF-primed allogeneic bone marrow on day 0. Patients then receive G-CSF SC beginning on day 5.
* Graft-versus-host disease prophylaxis: Patients receive cyclosporine beginning on day -1 and methotrexate on days 1, 3, and 6.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hematologic malignancy or nonmalignancy
* Candidate for matched, related-donor, allogeneic bone marrow transplantation
* Availability of an HLA-matched (6/6) related donor

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2 OR
* Karnofsky or Lansky 70-100%

Life expectancy

* At least 12 weeks

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No significant functional deficit of any major organ

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior stem cell transplantation
SFX-01 After Subarachnoid Haemorrhage

This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

The study is a randomised, double-blind, parallel-group design comparing SFX-01 (300 mg) taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily for up to 28 days versus placebo in 90 patients who have had SAH and present within 48 hours of ictus.

Subjects will receive SFX-01/Placebo in order to review potential outcomes investigating the long-term complications of SAH such as Delayed Cerebral Ischaemia, as reflected by Trans-Cranial Doppler (TCD) readings. The objective is to demonstrate safety and search for signals of efficacy in patients that have had SAH.

A sub-study will be conducted in up to 12 patients where an External Ventricular Drain (EVD) fitted; serial CSF samples will be taken pre- \& post-dose on two occasions to determine pharmacokinetics of Sulforaphane in CSF in comparison with plasma pharmacokinetics. Sub-study patients will undergo all other procedures (with the exception of lumbar puncture).

Treatment duration is up to 28 days; follow up duration is 28 days, three and six months. The planned trial period is 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with radiological evidence of spontaneous SAH
2. Fisher grade 3 or 4 on CT
3. Definitive treatment of aneurysm has not been ruled out
4. Previously living independently
5. In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours
6. Aged 18 to 80 years
7. In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose

Exclusion Criteria:

1. Traumatic SAH
2. Fisher grade 1 or 2
3. SAH diagnosed on lumbar puncture with no evidence of blood on CT
4. Decision not to treat aneurysm has been made
5. Plan to withdraw treatment
6. Significant kidney disease as defined as plasma creatinine ≥2.5mg/dL (221 µmol/l)
7. Liver disease as defined as total bilirubin ≥2-fold the upper limit of normal; (ULN) as measured by the local laboratory
8. Females who are pregnant or lactating.
9. Participants enrolled in another interventional research trial in the last 30 days
10. Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.


Eligibility Criteria:
Inclusion Criteria:

* Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
* History of disabling migraine for at least 1 year.
* Migraine Disability Assessment Test (MIDAS) score ≥11.
* Migraine onset before the age of 50 years.
* History of 3-8 migraine attacks per month and \<15 headache days per month during the past 3 months.

Exclusion Criteria:

* Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.
* History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.
* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.
* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).
* History of orthostatic hypotension with syncope.
Assessment of Drug Prescription by Phone

Prescription of medicines by telephone in French medical call Centres is a part of the general practitioners activity.

This study aimed to described drug prescription by phone (MTP) performed in four medical call centers. The primary objective is to evaluate adherence to french practice guidelines for the drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective is to evaluate the risk/benefit ratio for drug prescription by phone.


Eligibility Criteria:
Inclusion Criteria:

* All phone calls, from september to october 2013, leading to a drug prescription by a general practitioner of four medical call centres..

Exclusion Criteria:

* Medical emergency
* Patient refusing or not able to provide consent.
A Study of Plant-based Diet on Postprandial Sleepiness

This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.


Eligibility Criteria:
Inclusion Criteria

* Sleepiness after eating lunch.
* ESS score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'.

Exclusion Criteria

* Diabetes.
* Pregnancy or lactation.
* Current use of a vegan/plant-based diet
* BMI ≤ 22.
* Iron deficiency.
* Vitamin B12 deficiency.
Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)

This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).

This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort until the Maximum Tolerated Dose (MTD) is determined. Up to three additional subjects per cohort may be enrolled if each additional subject is known to be positive for Anaplastic Lymphoma Kinase (ALK) or Proto-Oncogene Tyrosine-Protein Kinase ROS (ROS) abnormalities. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. Intra-subject dose escalation will be allowed at the discretion of the investigators. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Once the MTD is determined, approximately 20 additional subjects with Anaplastic Lymphoma Kinase (ALK) abnormalities will be enrolled at the Recommended Phase 2 Dose. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria:

  * Disease progression despite standard therapies
  * No standard therapies are available or such therapies are not anticipated to result in a durable response
  * Standard therapies are considered unsuitable or have been refused
* Able to take oral medications
* Life expectancy \> 12 weeks
* For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities
* Subjects with stable brain metastasis will be allowed

Exclusion Criteria:

* Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
* Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
* Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
* Cardiac arrhythmias \> Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03
* Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
* Inadequate bone marrow, renal, and/or hepatic function
* Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
* Known history of long QT syndrome
A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability

This study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must indicate that they currently have weakened ankles or knees and that they experience chronic discomfort after performing daily activities.
* Subjects must suffer from pain assessed on a 100 mm (10 cm) Visual Analog Scale (VAS) of ≥20 mm to ≤ 90 mm for subjects with either unstable ankle or unstable knee, at Visit 1 and 2.
* Subjects must be able to walk unaided by cane or walker.
* Subjects must not have a noticeable limp or other permanent ailment that interferes with normal gait.
* Subjects free of other types of health problems that, in the opinion of the Investigator, could influence their ability to participate.
* If subjects are taking pain medication (prescription or Over-the-counter (OTC)) for a chronic condition, they may continue that medication as long as they have been on a stable dose for at least 2 months, and agree to continue their regular dose and regimen for the duration of the study.
* Subjects must be willing to undergo a 1-week period without a brace and then willing to wear a brace for a 1-week period, that is: 8 ±2 hours a day for a minimum of 5 out of 7 days.

Exclusion Criteria:

* Subjects with an ankle or knee pain and instability which is due to a recent sprains, strains, or other non-reversible injury to the knee or ankle.
* Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in the ankles, knees, or feet or any problems that would make brace wear uncomfortable or inappropriate.
* Subjects who wear a physician-prescribed orthotic device, prescription shoes or back braces.
* Subjects who are undergoing traction or manipulative back adjustments or have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining Investigator would interfere with the study evaluations.
* Subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study.
* Subjects who are currently taking an opioid based pain medication or have taken such medication within 2 months prior to Visit 1.
* Subjects who are taking any chronic pain medication (prescription or OTC) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study.
* Subjects who have severely painful bunions, warts, corns and/or calluses, severely overlapping toes or lesions on the bottom of their foot.
* Subjects who have sensitivities or allergies to plastics or adhesives.
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fasting Conditions

Objective:

To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.

Study Design:

Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Sex: male.
  * Age: 18 - 45 years. .
  * Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  * Healthy and willing to participate in the study.
  * Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  * Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  * Clinically significant abnormal ECG or Chest X-ray.
  * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  * Pulse rate less than 50/minute or more than 100/minute.
  * Oral temperature less than 95°P or more than 98.6°P.
  * Respiratory rate less than 12/minute or more than 20/minute
  * History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  * History of alcohol or drug abuse
  * Positive breath alcohol test
  * Recent history of kidney or liver dysfunction.
  * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  * Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  * History of heart failure.
  * HIV, HCV, HBsAg positive volunteers.
  * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - Cocaine positive volunteers based on urine test.
  * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  * Administration of any study drug in the period 0 to 3 months before entry to the study.
  * History of significant blood loss due to any reason, including blood donation in the past 3 months.
  * History of pre-existing bleeding disorder.
  * Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia

Specific Written Language Disorders (SWLD) are severe and lasting impairments in the development of written language that affect approximately 10% of the school-age population.Concerned patients don't have any intellectual disability.

Speech therapy help them to improve their language skills but also to compensate for their difficulties.

School environment is one of the places where these disorders can constitute a real handicap.

Given the prevalence of disorders, governments but also supra-governmental authorities have promoted educational integration of the concerned patients around the world. In France, different systems exist to help these patients with SWLD to follow an education that allows them to update their capacities as much as possible. School facilities are proposed such as attribution of Assistive Technology (AT). Nevertheless, these facilities have some limitations.

Concerning AT, several studies have shown the benefits for patients with dyslexia such as a better use of them. However, there were some limitations in their use and their usefulness.

The lack of use training is one of the barriers cited by patients and caregivers (parents and teachers).

Assistive Technology training exists for patients with dyslexia but very few studies have measured their influence on their performance in written language. Moreover, these studies did not take into account the previous level of computer practice nor the natural appropriation of the AT (ie: anyone can appropriate themselves). It is therefore difficult to affirm the specificity of the training's influence.

This study aims to assess the usefulness of AT training on the written language performance of adolescents with dyslexia. This work will study teenager's autonomy and how they use these tools.


Eligibility Criteria:
Inclusion Criteria:

* adolescents with dyslexia
* normal schooling (not in a specialized establishment)
* with attribution of assistive technology less than 3 months or planned soon or low usage

Exclusion Criteria:

* oral disabilities hindering intelligibility
* physical disabilities (hands) hindering use of AT
* auditive and visual disabilities