cyrilzakka/clinical-trials huggingface dataset:
Paracetamol With Caffeine to Treat Episodic Tension Type Headache

This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of episodic tension-type headache consistent with all of the following:

  1. number of days with the condition is historically greater than or equal to two per month
  2. onset of condition was greater than or equal to 12 months from Visit 1
  3. age of onset was \< 50 years
  4. severity of headaches is historically at least moderate
  5. duration of headaches is historically greater than or equal to four hours, if untreated
  6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
  7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours

Exclusion Criteria:

* Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
* If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Paravertebral Block for Mastectomy with Immediate Reconstruction

Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.

The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* woman scheduled for unilateral mastectomy with immediate reconstruction

Exclusion Criteria:

* Patients who will have an axillary dissection during surgery.
* Woman with severe hepatic insufficiency (Child Pugh Classification B and above24).
* Woman with kidney failure stage 4 and above25.
* Body mass index (BMI) \> 40 kg/m2.
* Woman with an allergy to local anesthetics.
* Woman with a bleeding disorder in whom BPV is contraindicated.
* Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia.
* Woman with a single lung.
* Pregnant woman.
Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥18 years
* Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or metastatic, inoperable NSCLC \[Stage IIIB/IV\]. Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion.)
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease on computerized tomography (CT) scan
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent

Exclusion Criteria:

* More than 2 prior chemotherapy regimens
* Progression of disease on prior pemetrexed treatment
* Brain metastases (exception: patients who had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
* Serum creatinine ≥2.0mg/dL or creatinine clearance \<45mL/min
* Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
* Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.
Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate

The significant vascularity of the thyroid gland and the relatively small operative field makes meticulous hemostasis an important prerequisite in thyroid surgery for successful outcome. The mainstay for achieving hemostasis in thyroidectomy is tying and / or clipping of blood vessels. New technologies have been introduced , among them the vessel sealing device ( ligasure ) which seals vessels by fusing the inner layers of the vessel wall with minimal levels of thermal dispersion burning and tissue friction thereby reducing incidence of accidental burns . This study is designed to evaluate the safety and efficacy of using ligasure compared with conventional vessel ligation in open thyroid surgery

Eligibility Criteria:
Inclusion Criteria:

* Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
* Any age

Exclusion Criteria:

* patient undergoing re-do surgery " completion thyroidectomy "
* patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
Cryptosporidium Infection and Human Colorectal Cancer

It has been reported that Cryptosporidium parvum, a species of a protozoan frequently isolated from humans and animals, is able to induce digestive adenocarcinoma in a rodent model. Consistently, some epidemiological studies have reported an association with cryptosporidiosis in patients with colorectal adenocarcinoma. However, the correlation between cryptosporidiosis and human digestive cancer remains unclear at this time, and it is not known whether this intracellular parasite, considered an opportunistic agent, is able to induce gastrointestinal malignancies in humans. In order to add new arguments for a probable association between cryptosporidiosis and digestive human cancer, the main aim of this study is to determine prevalence and to identify species of Cryptosporidium among a French digestive cancer population.


Eligibility Criteria:
Inclusion Criteria:

Cases:

* Age ≥ 18 years old
* Patients with colonic adenocarcinoma/intraepithelial neoplasia diagnosed prior to chemotherapy or radiotherapy who will undergo scheduled surgery. Patients with rectal cancer with indication for neoadjuvant treatment will still be included, but only biopsies used for diagnosis will be used
* Patient capable of receiving informed information
* Written informed consent
* Affiliation to a social security scheme

Controls:

* Age ≥ 18 years old
* Patients with endoscopic indication for benign pathology
* Patients with indication for colectomy for benign pathology
* Patients with digestive cancer (stomach, oesophagus, biliary, pancreatic, etc.) of any type other than colorectal cancer before chemotherapy or radiotherapy
* Patient capable of receiving informed information
* Written informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Patients undergoing pre-operative chemotherapy.
* Patients who have already had chemotherapy for less than one year or other immunosuppressive treatment
Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire

The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.


Eligibility Criteria:
Inclusion Criteria:

1. Age is 18 years old or older
2. Written consent to participate in the study
3. All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.
4. Eligible for catheter-based diagnostic or treatment procedure. A representative list of diseases and catheter-based treatments includes:

   Suspicion of obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing Suspicion of peripheral vascular obstructive disease undergoing elective or urgent diagnostic and/or percutaneous therapeutic procedures.
5. Palpable pulse of the proximal and distal radial artery on one or both arms
6. Subjects must be suitable for a transfemoral vascular access
7. Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
8. Subjects with suspected narrowed or blocked arteries in the heart.

Exclusion Criteria:

1. Inability to provide consent
2. Pregnant or lactating women
3. Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
4. Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
5. Subject has a known allergy to the Guide Wire materials
6. Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.
7. Subjects with severe infections
8. Subjects with severe heart failure
9. Subjects with severe physical weakness
Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial which aims to investigate the superiority of hydroxychloroquine, favipiravir or hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the treatment of COVID-19, over the patients being followed up with placebo in adults aged 18\~59 Years.

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial in in adults aged 18\~59 Years. The study was planned as a multicenter, randomized controlled, double-blind, parallel-arm drug study. The purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine, favipiravir, or hydroxychloroquine + favipiravir treatments that were initiated early in patients who were caught during filiation or who were decided to be outpatient due to mild disease findings during hospital admission, after the diagnosis of COVID-19 against patients with placebo. It is planned that the study will be conducted with two separate arms. Study arms are planned as 2:2:2:1 for 320:320:320:160 patients as follows. The dose of Favipiravir has been determined as the standard dose. Hydroxychloroquine will also be given without a loading dose.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers who have understood all the procedures to be applied within the scope of the study protocol and gave their consent.
2. Patients between 18-60 years old.
3. Patients whose symptoms and complaints associated with COVID-19 started within 48 hours.
4. Mild cases whose treatment to be given as outpatient.

   1. Although asymptomatic, patients with high CRP (\> 20 mg/L) and/or lymphopenia (\<1000/mm3)
   2. Patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell.
   3. Patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions)
   4. Patients with normal chest x-ray and / or chest tomography (no sign of pneumonia)
5. Patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol.
6. Patients who were not involved in any other interventional study.

Exclusion Criteria:

1. Patients who do not give their consent in writing after informing.
2. Being under the age of 18 and over the age of 60.
3. Patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir).
4. Volunteers who the researcher thinks may have problems with adherence to treatment.
5. Volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea.
6. Patients with chronic liver disease and transaminase (ALT or AST) levels 5 times the higher than the normal level.
7. Patients with heart disease or arrhythmia history.
8. Patients with gout or hyperuricemia.
9. Patients with signs of pneumonia in their lungs.
10. Patients with chronic renal failure (glomerular filtration rate \<30).
11. Pregnant or breastfeeding patients.
Hemodynamic Instability Index: The Impact to Care With a New Predictive Indicator

Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill patients, who were not previously known to be at risk. This algorithm provides with the numerical index - Hemodynamic Instability Index (HII) and its trend which are calculated from existing real time data derived from patient's current hospital stay such as heart rate and blood pressure, labs, and Admission - Discharge- Transfer (ADT) data to help healthcare providers obtain information about patient's status and make clinical decisions.

The aim of the study is to determine if the patient clinical information, displayed in the form of HII, can prompt possible patient hemodynamic status change and trigger earlier clinical care team response. We hypothesize that this real-time information on hemodynamic instability and earlier clinical decision making will lead to reduced length of stay (LOS) and ICU mortality relative to standard care practice. Study will also identify if the use of the Philips new algorithm called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve outcomes for patients admitted to the intensive care units (ICUs).

During this study, upon patient admission to the ICU clinical data collection will begin. Data that will be pulled during the study includes: vital signs, medications, reason for admission to the ICU, treatments that patient may receive.

Research subjects will not be asked to do anything as far as specific activities expected to be accomplished during study participation. Subjects will be involved in the study only during their stay in ICU. HII information will be visible to clinicians, taking care of this patient only during his/ her stay in the study unit.

Study team will collect patient information and have the ability to view the HII for subjects.

Once patient leaves the ICU the study team will collect information on the remainder of patient's hospital course including date of hospital discharge. All collected data will be then fully de-identified and released to Philips for analysis.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the study unit will be invited to participate in the study.
* Study subject has to stay in study unit for at least 12 hours.

Exclusion Criteria:

* Patients who were discharged from study unit earlier then 12 hours after admission.
* Patients who are or become dependent on extracorporeal membrane oxygenation (ECMO) support.
Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma

This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields.

The study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial.

In this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation.

For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).

Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.

Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study.

Patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation.

MRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. Patient with newly diagnosed glioblastoma.
3. Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.
4. Signed written informed consent.
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Any condition contraindicated with sampling procedures required by the protocol.
2. Any contraindication to the use of the medical device administering TTFields.
3. Simultaneous participation in a therapeutic interventional clinical trial.
4. Patient pregnant, or breast-feeding.
5. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Mortality in Paediatric Intensive Care

Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017

Mortality of paediatric patients in intensive care can be considered as on of the parameters of quality of care. Together with the advance in research and medicine there should be a trend towards mortality reduction, however actual data in Czech Republic are not well documented. The aim of this retrospective cohort trial was to evaluate the mortality of paediatric intensive care patients admitted to Department of paediatric anaesthesiology and intensive care between two periods 2008-2012 and 2013 and 2017. The patients records was retrospectively searched and the mortality was adjusted according to the primary admission diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients admitted to intensive care in selected time period

Exclusion Criteria:

* Insufficient documentation
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.


Eligibility Criteria:
Inclusion Criteria:

* Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
* Ordered respiratory treatment of NCPAP

Exclusion Criteria:

* Major congenital defect
* Known or suspected chromosomal disorder