cyrilzakka/clinical-trials huggingface dataset:
A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

* The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses
* How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks
* How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal
* How LY2409021 works when given with metformin
* How daily dosing of LY2409021 affects the cells that produce insulin


Eligibility Criteria:
Inclusion Criteria:

* Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
* Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
* Have a screening body mass index (BMI) of 20 to 40 kg/m\^2 inclusive
* Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Exclusion Criteria:

* Have used insulin for diabetic control within 1 year of study entry
* Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
* Have clinically significant coronary artery disease
* Have clinically significant peripheral vascular disease
* Have clinical evidence of active diabetic proliferative retinopathy
* Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
* Impaired renal function (serum creatinine greater than 115 micromoles/liter \[μmol/L\] \[1.3 mg/dL\] in women, greater than 130 μmol/L \[1.5 mg/dL\] in men)
* Have triglycerides greater than 4.5 millimoles per liter (mmol/L) \[approximately 400 mg/dL\] at screening
* Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
* Are allergic to LY2409021 or similar drugs
* Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
* Have used systemic glucocorticoids within 1 month prior to first dosing
* Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa

The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)

Specific Objectives:

1. To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced usual care in South Africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth).
2. To examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both CHWs and patients.

Eligibility Criteria:
Inclusion Criteria:

1. Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation
2. Living in Khayelitsha
3. 18 years or older
4. Screen positive for depression with a cut off of 13 or more on the EPDS
5. Able to give informed consent

Exclusion Criteria:

* Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis.
* Women who do not speak isiXhosa as a first language
Neuroaxial Labour Analgesia

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous parturient
2. Singleton, vertex gestation at term (37-42 weeks)
3. Less than 5 cm dilation
4. request an epidural technique for labor analgesia

Exclusion Criteria:

1. Hypersensitivity to local the study drugs
2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
3. Any contraindication to the administration of an epidural technique
4. Risk factor for cesarean delivery.
5. fetal anomalies
A Safety and Effectiveness Study of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Pain Associated With Ankle Sprains.

The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains.

The objective of this randomized, double-blind, parallel-group study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of Grade I and Grade II lateral ankle sprains. The primary efficacy endpoint is the change from baseline (Day 1) to Day 4 in the subjects' pain upon walking. Safety assessments consist of the monitoring of adverse events and assessments of the ankle injury during the course of the study. Two hypotheses are examined using a step down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with (Grade I or Grade II) lateral ankle sprains. If acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains, the second hypothesis is that acetaminophen extended release is superior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for nine days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for nine days

Eligibility Criteria:
Inclusion Criteria:

* Have had an ankle sprain within 24 hours of study entry
* have ankle pain when walking
* have not recently used non-steroidal, anti-inflammatory drugs (NSAIDs), other pain relieving medications (including acetaminophen) or medicines that could interfere with the assessment of effectiveness
* if female, must not be pregnant or breastfeeding

Exclusion Criteria:

* Ankle sprain was the second ankle sprain within six months
* Both ankles were sprained
* Ankle sprain occurred on the same side of the body as a knee injury
* Ankle injury requires bed rest, hospitalization, surgical intervention, or use of a non-removable rigid cylindrical cast
* Subject reports severe or very severe pain at rest on a five-point scale of none, mild, moderate, severe or very severe
Genomic Landscape of Intramedullary Astrocytoma

intramedullary astrocytoma is a rare and devastating spinal cord glioma. while the management of intracranial astrocytoma includes gross total resection, radiotherapy and chemotherapy, spinal cord astrocytoma is very difficult to be totally removed due to its infiltrative nature and unclear plane of dissection; Moreover, the use radiotherapy and chemotherapy for spinal cord astrocytoma is controversial. Therefore, the treatment for spinal cord astrocytoma is very limited as compared to its intracranial counterpart. Inadequate understanding of spinal cord astrocytoma mainly contribute to limited treatment, while the molecular profiling of intracranial astrocytoma is relatively well understood. Hence, we performed whole-exome sequencing of intramedullary astrocytoma aiming to identify the pathophysiological mechanisms underlying spinal cord astrocytoma

Intramedullary tumor only account for 2-4% of central nervous tumor. Of which, ependymoma and astrocytoma represent the most common intramedullary tumor. Although intramedullary astrocytoma is rare, it can cause significant mortality and morbidity. Different from its intracranial counterpart which can receive gross total resection and standard adjuvant treatment, intramedullary astrocytoma always cannot be removed completed due to its infiltrative nature and, additionally, radiotherapy and chemotherapy is controversial. Therefore, the treatment for this tumor is very limited. While the genetic profiling of intracranial astrocytoma is relatively well understood and standard treatment strategy has been developed, genetic alteration of intramedullary astrocytoma is less well understood. Identification of the molecular profiling can lead to well understanding of the pathophysiological mechanisms underlying intramedullary astrocytoma and more effective therapeutic strategy in future. Hence, we performed this study aiming to investigate the genetic profiling of intramedullary. All patients with intramedullary astrocytoma underwent surgery in our institution will be enrolled. Tumor tissue and matching blood will be obtained after the surgery. Whole-exome sequencing was performed on DNA extracted from these specimens. Moreover, demographic information, progress-free survival and overall survival will be evaluated in 3 year of follow-up after the initial diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* patients that histologically diagnosed as primary spinal cord astrocytoma

Exclusion Criteria:

* patients with spinal cord tumors rather than astrocytoma
* metastatic astrocytoma
* tumor sample can not be obtained
Mirtazapine Versus Placebo in Functional Dyspepsia

Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily

Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine

Two weeks run-in, 8 weeks randomized, 8 weeks open label

Assessments include

* dyspepsia questionnaire
* Nepean dyspepsia index
* Daily diary
* Vital signs

Eligibility Criteria:
Inclusion Criteria:

* Functional dyspepsia according to Rome II criteria
* Weight loss of \> 5% body weights

Exclusion Criteria:

* Organic GI pathology
* History of upper gi tract surgery
* Major depression or anxiety
* Use of antidepressants in the last 2 months
* Prokinetic drugs or spasmolytic drugs
* Analgesic use (except paracetamol)
* Pregnancy or lactation
Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.

OBJECTIVES:

Primary

* To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.

Secondary

* To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.

OUTLINE:

* Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
* Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:

  * Squamous cell carcinoma
  * Poorly differentiated carcinoma
  * Lymphoepithelioma
* Locally advanced disease (stage III or IV \[M0\] disease)
* At least 1 unidimensionally measurable index lesion

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3.0 times ULN
* AST and ALT ≤ 3.0 times ULN
* Creatinine ≤ 1.5 times ULN
* No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
* No serious cardiac condition, including any of the following:

  * Myocardial infarction within the past 6 months
  * Angina
  * NYHA class III-IV heart disease
* No active infection requiring IV antibiotics, including active tuberculosis or HIV
* No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Able to comply with protocol or study procedures

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or chemotherapy
Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria

1. Male or female patient ≥ 50 yrs. of age.
2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.
3. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
2. Presence of active intraocular or periocular inflammation or infection;
3. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
4. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
5. Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;
Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study

Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values and cut-off points for this technique based on cellular components of IS, such as percentages of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However, normal values and cut-off points for lymphocyte percentages indicative of pathology have not yet been established or validated. This component of IS has considerable clinical value. Similar to other constituents of IS, it can provide biological insights into the pathogenesis of respiratory disorders and contribute to establishing the diagnosis and guiding treatment management of a variety of airway diseases.

The purposes of this study are to define normal values and cut-off points of lymphocytes in IS among individuals with respiratory disorders and healthy volunteers, and to verify the current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in IS.

Methods: A Cross Sectional study which includes a database on up to 900 patients who participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky Medical Center between 2005 to 2012 will be established. The study population will include patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and evaluating sensitivity and specificity. The comparison of the different values to those in the literature will be done by using the Spearman rank correlation.

The results of this study will provide supplementary information on lymphocyte counts in IS for identifying and treating various respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from pulmonary symptoms or diseases
* patients with occupational or environmental exposure

Exclusion Criteria:

* indefinite spirometry tests
Propagation Waves in Tactile Material Perception

During the exploration of surfaces with the bare finger, vibratory signals arise and propagate through the finger and hand. While research into mechanical and neural response characteristics has demonstrated that these signals carry rich information about touched objects and their properties, only little is known about the role these propagation waves play in human perception and to which extent the somatosensory system is able to collect information from afferents at more proximal locations than the skin-object surface. Using ring-block anaesthesia (lidocaine) we will temporarily inhibit haptic feedback sensations of healthy participants' index finger during interactions with 3D-printed surface probes that are systematically varied in two important material dimensions, namely their roughness and hardness (elasticity), while the participants carry out a well-established psychophysical discrimination task. The results will then be compared to a control condition without anaesthesia. An accelerometer sensor, placed on the dorsal side of the hand, will serve to simultaneously record the propagating tactile waves. Given their role in material perception, thermal cues will be monitored during the experiment with a thermometer and the hydration level of the fingertip skin will be measured regularly using a corneometer. This research will allow us to understand the role of propagation waves in material perception. It seeks to uncover some of the perceptual mechanisms that remain intact during surface discrimination of textured, compliant surfaces, while local information is temporarily inhibited. The results will have implications for how we provide feedback about material properties for sensorimotor control to this living with prosthetic limbs. It is hypothesised that propagation waves that arise during these haptic interactions contain behaviourally relevant information used for the discrimination of surface properties.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* No reported psychiatric or neurological disorders;
* Able to provide informed consent;
* Voluntary participation with written informed consent.

Exclusion Criteria:

* Is pregnant or currently breastfeeding;
* Has a known Lidocaine allergy;
* Is currently undergoing any other medical intervention or taking part in a study involving one;
* Has a history of finger/hand/upper limb trauma or disease;
* Has a disease affecting normal motor functioning.
Value of Flow Cytometry in Infectious Point of Care: Feasibility Study

The purpose of this project is to validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.

This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers.

The detection and characterization of infectious events is a major challenge for emergency medicine. Thus the possibility of quickly attributing an infectious origin to a febrile and/or inflammatory syndrome makes it possible to treat and refer the patient quickly. In addition, the ability to distinguish bacterial etiology from viral etiology provides a valuable additional indication for the clinician. This of the upmost importance for fragile populations such as elderly patients and in epidemic conditions such as influenza. A new rapid diagnostic guidance solution is proposed by the Beckman Coulter Laboratory with the simultaneous assay of two biomarkers, one allowing the detection of a viral infectious process (CD169), the other of a bacterial infectious process (CD64). The combination of these two biomarkers, measured in 12 minutes by a new generation assay and flow cytometer, represents an opportunity for emergency services.

To date, there is no study on the validation of this diagnostic orientation method. We propose to carry out a prospective, observational, non-interventional feasibility study to compare the results of these measurements with the usual diagnostic criteria combining the clinical signs, infectious testing, and biological data.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association:

  * A fever\> 38 ° C or hypothermia \<36.5 ° C.
  * A potential clinical infectious syndrome is respiratory (cough, sputum, dyspnea), or urinary (potential urinary tract infection), or abdominal (potentially infectious diarrhea, potentially infectious pain syndrome) or neurological (meningitis potential) or cutaneous (erysipelas).

Exclusion Criteria:

* Patients with clinical criteria that may increase other non-specific biomarkers and therefore not allow for subsequent comparison:

  * Trauma
  * Known inflammatory and autoimmune disease
  * Infectious chronic viral, fungal or bacterial disease
  * Antibiotic or anti viral treatment prior to admission
  * Immunosuppressive treatment
  * neoplasia
  * Extended burn
  * Recent surgery (\<1 month)