cyrilzakka/clinical-trials huggingface dataset:
The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients

The aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients with head and neck cancer and (2) the waiting times to diagnosis and therapy, and the 1-, 3- and 5-year survival of patients. We plan to gain insight into the characteristics and pathways of head and neck cancer patients in Baranya County, which can in turn help to identify factors that lead to improved or worse disease outcomes. (Thus, these factors can subsequently eliminated or lessened to improve the outcome of head and neck cancer patients. )

The aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients (including initial symptoms) with head and neck cancer and (2) the patient pathways and waiting times to diagnosis and therapy, the 1-, 3- and 5-year survival, and time to metastasis of patients.

Study design:

Prospective data collection and analysis, based on data collected from the clinic's electronic eMedSol database and questionnaire (regarding demographic, lifestyle and patient pathway-related data) filled in by interviewing patient.

We plan to monitor lifestyle parameters of patients (such as oral hygiene, alcohol consumption and smoking, the knowledge of patients about risk factors of head and neck cancers,etc) and clinical parameters such as time and type of first symptom, ECOG state, comorbidities, clinical stage, diagnostic workups, etc. at predetermined time intervals (upon first ENT presentation, and at 3-, 6-, 12-, and 24 month intervals.

Disease progression (time to metastasis) and overall survival will be assessed at the given time points.

By gathering data and gaining insight into the characteristics, pathways and survival of head and neck cancer patients we aim to identify factors that may lead to improved or worse disease outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or over presenting with head and neck cancer (with morphology of squamocellular carcinoma), who are subsequently given one of the following ICD-10 codes: Malignant neoplasms of lip, oral cavity and pharynx (C00-C14), Malignant neoplasm of larynx (C32) and for whom this is their first cancer.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria and patients who meet the inclusion criteria but for whom this is a second or recurrent cancer (they already have an "ICD-C" code) are excluded from the study
IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain

This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.

Study Design and Setting:

This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.

Interventions:

We conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with suspected low back pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment.

Methods of Measurements:

Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain' and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe pain) just before the drug administration, 15th minutes and 30th minutes after the study drug administration. The demographic features of study patients and adverse effects, nausea, vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry mouth, were recorded to the study form.

Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence of any adverse event.

Primary Data Analysis:

The present study was planned as a superiority trial. When the 20 mm difference in VAS is accepted as clinically significant and the standard deviation is accepted as 25 mm, 35 patients are needed with each group with 95% power. All the analysis were implemented according to the intention to treat analysis. The precise of differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- -

Exclusion Criteria:

* Exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen or any opioid analgesic
* Hemodynamic instability
* Fever (temperature \>38°C \[100.4°F\])
* Evidence of peritoneal inflammation
* Documented or suspected pregnancy
* Known or suspected aortic dissection or aneurysm, lombar disc hernia
* Use of any analgesic within 6 hours of ED presentation
* Previous study enrollment.
* Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.
Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments

Study and evaluate the effectiveness of virtual reality in pain management.

Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.

For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.

* If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
* If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic.

If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).

The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.

The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.

The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 09 and 24 years
* suturing a wound
* changing a dressing
* lumbar puncture,
* peripheral venous line
* blood test
* intramuscular injection
* reduction of a fracture
* casting or plastering.

Exclusion Criteria:

* impaired consciousness
* epilepsy
* wound/infection covering the helmet area
* headache
* intellectual/mental retardation
* nausea, vomiting
* patient already included in the protocol
* pain requiring immediate medical attention. analgesic (VAS \>5 and described as intolerable).
FemBloc® Permanent Contraception - Confirmation Feasibility Trial

The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.


Eligibility Criteria:
Inclusion Criteria:

* Female, 21 - 45 years of age desiring permanent birth control
* Sexually active with male partner
* Regular menstrual cycle for last 3 months or on hormonal contraceptives

Exclusion Criteria:

* Uncertainty about the desire to end fertility
* Known or suspected pregnancy
* Prior tubal surgery, including sterilization attempt
* Prior endometrial ablation
* Presence, suspicion, or previous history of gynecologic malignancy
* Abnormal uterine bleeding requiring evaluation or treatment
* Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
* Allergy to shellfish, betadine or iodinated contrast
Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.

Dual antiplatelet therapy, comprising a low-dose aspirin and a kind of P2Y12 Receptor Inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing Percutaneous Coronary Intervention (PCI). While variability to P2Y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. Low response to P2Y12 receptor inhibitors will result high platelet reactivity (HPR) and patients who exhibit HPR are at increased risk of atherothrombotic occlusion events. Vice versa, high response to P2Y12 receptor inhibitors will lead to low platelet reactivity (LPR) and increase the risk of hemorrhage.Now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.So this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for P2Y12 receptor inhibitors in Chinese people.

Eligibility Criteria:
Inclusion Criteria:

* Chinese's patients diagnosed with coronary heart disease and accept stent implantation.
* Accept aspirin and P2Y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation.
* Willingness and ability to sign informed consent.
* Can communicate effectively and complete the trial.

Exclusion Criteria:

* Occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing.
* Allergy or intolerance to aspirin or P2Y12 receptor inhibitors (Clopidogrel or Ticagrelor）
Plan for Testing Fingerstick Bloods on Magellan Systems

This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects who consent to a capillary blood collection

Exclusion Criteria:

* Patients are not currently taking chelating agents, e.g., penicillamine, succimer
Effect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia

The aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with Alzheimer's Dementia.

The aim of study is to investigate the effect of virtual reality application on balance and gait speed in individuals with Alzheimer's Dementia. The study consisted of 32 subjects, which were diagnosed as mild or moderate AD by the neurologist. The balance, fall risks and gait speed were assessed. Training group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week.

Eligibility Criteria:
Inclusion Criteria:

* Having mild or moderate severity of AD
* Lack of communication difficulties or problems
* Volunteering to participate in the study
* Cerebrovascular event,
* Having disturbing the balance and coordination of neurological disease such as Parkinson, MS,
* Mini Mental Test Score, 18 to 24 points from being scored
* being 65-80 aged.

Exclusion Criteria:

* Patients diagnosed with dementia (infection, vascular, hematological diseases), patients who could not be contacted during the follow-up period or who did not come to control, cardiac and cerebrovascular event,
* Endocrine disorder, fluid-electrolyte imbalance and infection
* Patients with malignancy and malignancy, chemotherapy and radiotherapy,
* Patients with delirium or depression
* Those with protective sensation loss (those with Semmes-Weinstein Monofilament Thickness 4.56 and above)
* patients with lower or upper extremity amputations at any level
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Males/females with CDAD
* Females must use adequate contraception
* Signed informed consent

Exclusion Criteria:

* Life-threatening CDAD
* Toxic megacolon
* Pregnant
* Concurrent use of diarrheal agents
* Participation in other trials
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study

Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. This will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Men age 18-70 years
* Postmenopausal women age 55-70 years
* Non-smoker (abstinent at least 6 months)
* HbA1c \< 74 mmol/mol
* Fasting blood glucose \< 11 mmol/L (mean of 3 measurements)
* Negative (\<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG)
* Hemoglobin \> 7.5 mmol/L (men); \> 6.8 mmol/L (women)
* Normal thrombocytes (140-400 x 109/L)
* eGFR \> 45 ml/min per 1.73 m2
* Alkaline phosphatase \< 140 IU/L
* Alanine aminotransferase \< 70 IU/L
* Normal International Normalized Ratio (0.9-1.2)

Exclusion Criteria:

* Critical illness
* Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
* Steroid treatment e.g. prednisolone
* Reported or journalized severe food allergy or intolerance
* Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease
* Reported or journalized alcohol dependence syndrome
Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland

Sudden cardiac arrests is one of the most frequent causes of death. In Switzerland every year 8000-10.000 people suffer from a cardiac arrest. The EuReCa ONE Study showed regional differences in incidence and chances of survival after cardiac arrests in Europe. The current European Resuscitation Council (ERC) resuscitation guidelines 2015 recommend extracorporeal membrane oxygenation (ECMO) as treatment option for therapy refractory out-of-hospital cardiac arrests (OHCA). ECMO used under cardiopulmonary resuscitation (CPR) is called eCPR (extracorporeal CPR). In the year 2018 eCPR is started to be used in Bern, Switzerland. This study investigates retrospectively the survival and neurologic outcome of patients after OHCA in the region of Bern, Switzerland from 2015-2018. The data will be used as baseline for a prospective evaluation of eCPR cases.

The prospective Evaluation of e CPR will last from 2018 - 2022.


Eligibility Criteria:
Inclusion Criteria:

* All OHCA in the region of Bern, Switzerland in the year 2015-2017

Exclusion Criteria:

* if patient has previously declined to be included in a study (advance directive)
Comparison of Buprenorphine and Methadone - 3

The purpose of this study is to compare agonist and antagonist profile associated with buprenorphine vs. methadone during opiate withdrawal.


Eligibility Criteria:
Please contact site for information.
Exploration of Health Literacy in Diabetes in Reunion Island and France

The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\[s\] it aims to answer \[is/are\]:

Participants will complete the Health Literacy Questionnaire (HLQ) once.


Eligibility Criteria:
Inclusion Criteria:

Patient with type 1, 2 or gestational diabetes taken care in hospital

Exclusion Criteria:

* Patient unable to understand and respect study procedures
* Patient with cognitive disorder
* Patient with serious acute complication due to diabetes within 15 days before inclusion
* Stroke history with neurologic consequences
* Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance
Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease

Objective of the study:

To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology

Design:

Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.

Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .

There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation

Objective of the study:

To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology

Design:

Parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.

Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.

A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation)

Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology.

Sensors assessment:

The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks:

i) step length ii) step variability iii) step phases iv) turning speed

Eligibility Criteria:
Inclusion Criteria:

* established Parkinson's disease
* ability to stand alone and walk without support

Exclusion Criteria:

* dementia or behavioral alterations
* contraindication to stimulation
A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors

This is a multicenter, open label, dose escalation \& expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
2. ECOG performance status of 0 or 1.
3. Life expectancy ≥12 weeks.
4. Able to swallow and retain oral medication.
5. Subjects must have adequate organ function.
6. Use of effective contraception.

Exclusion Criteria:

1. Subjects receiving anti-cancer therapy at the time of enrollment.
2. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other systemic anti-cancer treatment, within 14 days prior to the first dose of CS3006 or who has not recovered from adverse events due to a prior therapy.
3. Receipt of any prior therapy with a MEK inhibitor.
4. Use of any investigational anti-cancer drug within 28 days before the first dose of CS3006.
5. Current use of a prohibited medication or use during treatment of CS3006.
6. Current use of warfarin.
7. Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
8. History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
9. Visible retinal pathology as assessed by ophthalmologic exam.
10. Intraocular pressure \> 21mm Hg as measured by tomography.
11. Glaucoma diagnosed within one month prior to the first dose of CS3006.
12. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
13. Primary malignancy of CNS.
14. Evidence of severe or uncontrolled systemic diseases.
15. Subjects with clinically significant cardiovascular disease.
16. QTc interval \>= 450 msecs for male or \>= 470 msecs for female
17. Known history of HIV.
18. Subjects with active Hepatitis B or C infection
19. History of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to CS3006.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com