cyrilzakka/clinical-trials huggingface dataset:
Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers

The purpose of this study is to estimate the effect of multiple doses of Rifampin on the single dose pharmacokinetics of Crizotinib in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non-child bearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects with evidence of disease, conditions affecting drug absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, and use of prescription , nonprescription drugs and dietary supplement within 7 days, and blood donation of 500 mL within 56 days.
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia

This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 35 years old
* Recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
* Good health status confirmed by a medical screening
* VO2max higher than 55 ml.min-1.kg-1
* Body Mass Index (BMI) between 18 and 25

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
* Intake of any medication or nutritional supplement that is known to affect exercise performance
* Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
* Blood donation within 3 months prior to the start of the study
* Smoking
* More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
* Involvement in elite athletic training at a semi-professional or professional level
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Investigating the Experiences of Individuals With Gastric Cancer Participating in Clinical Trials

This study is observational, meaning that it does not include any interventions or new treatments. As a result, there may not be an immediate benefit for the patient with gastric cancer.

However, the data collected from this trial can contribute to a better understanding of the factors that affect withdrawal and enrolment rates in gastric cancer clinical trials, and may ultimately lead to improved patient outcomes in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a minimum of 18 years or older
* Patient has been diagnosed with gastric cancer
* Patient has been self-identified as planning to enroll in an observational clinical study

Exclusion Criteria:

* Patient is breastfeeding or pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Thromboembolic Events in Severe COVID-19 Patients

The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events


Eligibility Criteria:
Inclusion Criteria:

* Confirmed infection with the Sars-CoV-2 virus (RT-PCR)
* Hospitalization in Intensive Care Unit
* Age over 18 years Old

Exclusion Criteria:

* Refusal of the patient to participate in data collection
Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

Measurements of dysphagia severity are important when making management decisions and in the objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a validated self-report inventory using a visual analogue scale. This questionnaire permits a quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia in different pathology. Opposed to largely used videofluoroscopy swallowing study and endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and enables a readily available assessment. Validated French version is not yet available. In the first phase of the study the investigators will validated this translation in dysphagic patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular patients.


Eligibility Criteria:
Inclusion Criteria:

Phase 1:

Group 1:

* Healthy participants
* Able to speak, read and write in French
* Aged at least 18 years old

Group 2:

* Patients, with symptoms indicative of a deglutition disorder, referred for a videofluoroscopic study to the Otolaryngology, Head and Neck Surgery Department, Voice and Swallowing Clinic
* Able to speak, read and write in French
* Aged at least 18 years old

Phase 2:

* Clinical diagnosis of neuromuscular diseases
* Able to understand French

Exclusion Criteria:

Phase 1:

Group 1:

* History of neurological or neuromuscular disease
* History of any diagnosticated swallowing disorder

Group 2:

* Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation
* Patients unable to answer the questionnaire

Phase 2:

* Patients who could not be cataloged as dysphagic or non-dysphagic
* Patients unable to answer the questionnaire
Continuous Glucose Monitoring (POC) in the ICU

The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.

Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course. The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated. Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached. These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery. Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* remain 1 week in an ICU
* 18-72 years old
* severe trauma or thermal injury greater than 20% TBSA burn

Exclusion Criteria:

* cerebral arterial injury
* myocardial infarction
* pre-existing renal failure or liver failure
* history of hypoglycemia
* history or high risk of seizures
* pregnancy
Low Load Resistance Exercises With Blood Flow Restriction Versus High Load Resistance Exercises

Practical blood flow restriction (PBFR) is a new technique of reducing the venous return using a band with a pressure that is applied using a perceived pressure scale. The studies that investigate the acute effect of using PBFR and regular high intensity exercises on the level of growth hormone (GH) and blood lactate (BL) after lower extremity training in collegiate athletes are scarce.

Practical blood flow restriction (PBFR) is a new technique of reducing the venous return using a band with a pressure that is applied using a perceived pressure scale. The studies that investigate the acute effect of using PBFR and regular high intensity exercises on the level of growth hormone (GH) and blood lactate (BL) after lower extremity training in collegiate athletes are scarce. Therefore, this study aimed to investigate the acute effect of a single session low load resistance exercises with PBFR compared to a high load resistance exercises without PBFR on the levels of GH and BL. A convenience sample of collegiate athletes were allocated to either an experimental group that performed low resistance exercises with PBFR or a control group that performed high resistance exercises without PBFR. The levels of GH and BL were examined in 3 time points: pre-training, immediate post-training, and 15 minutes post-training for both groups. Analysis of Variance (ANOVA) was used to assess the main and interaction effects of the groups.

Eligibility Criteria:
Inclusion Criteria:

* Student collegiate athletes.
* Age of 18 years and older.
* Free from any cardiovascular or respiratory disorders and did not have any injuries during the previous 12 months.

Exclusion Criteria:

* Students who were taking any medications for chronic conditions.
* Student who were taking any supplements.
Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.

inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 40-85 years old
* American Society of Anesthesiologists' physical status III and IV
* Planned for modified radical mastectomy with axillary lymph node dissection

Exclusion Criteria:

* Patient refusal
* Neurological or psychiatric disorders
* Local infection at injection site
* Spine or chest wall deformity
* Allergy or any contraindication to any of the study drugs
* Opioid or alcoholic addiction
* Chronic pain of any cause
* Uncooperative patients.
A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries

The purpose of this study to evaluate the effectiveness, safety, and tolerability of SUZ as part of multimodal therapy (MMT) in treating acute postoperative pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥)18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2)
* Participants scheduled to undergo an aesthetic or reconstructive surgical procedure that would typically be treated with opioid therapy for at least 72 hours postoperatively

Key Exclusion Criteria:

• Participated in a previous study with SUZ or received Journavx

Other protocol defined Inclusion/Exclusion criteria may apply.
Moxonidine for Prevention of Post-ablation AFib Recurrences

Hypothesis: Modulation of central nervous sympathetic activation by administration of moxonidine, a centrally acting medication which decreases the sympathetic nervous system activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment with pulmonary vein isolation.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients with paroxysmal atrial fibrillation.
* At least two documented episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours).
* At least one episode should have been documented under treatment with a class Ic or III antiarrhythmic drug.

Exclusion Criteria:

1. age \<25 or \>80 years
2. presence of atrial thrombus
3. left atrial volume index \>55 ml/m2
4. hypersensitivity to moxonidine
5. sick sinus syndrome or sino-atrial block
6. 2nd or 3rd degree atrioventricular block
7. bradycardia (below 50 beats/minute at rest)
8. estimated glomerular filtration rate \<40 ml/min/1.73 m2
9. history of angioneurotic oedema
10. heart failure symptoms OR impaired left ventricular function (EF \<40%), even if asymptomatic
11. stable or unstable angina pectoris
12. intermittent claudication or known peripheral artery disease
13. Parkinson's disease
14. epileptic disorders
15. glaucoma
16. history of depression
17. pregnancy or lactation
18. inability or unwillingness to adhere to standard treatment or to provide consent.
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.


Eligibility Criteria:
Inclusion Criteria:

* \<48 hours of age,
* 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
* Birth weight of ≥ 1,000 g,
* 5 minute Apgar score ≥5,
* Requiring nasal cannula O2 \> 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
* Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%,
* Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge.

Exclusion Criteria:

* Major congenital anomaly
* Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
* Known congenital infection (bacterial, viral),
* Perinatal asphyxia (5 minute Apgar \<5, umbilical artery pH \< 7.0 or evidence of neonatal encephalopathy),
* Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
* Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life,
* Any condition which could preclude receiving study drug or performing any study-related procedures,
* Use of postnatal corticosteroids,
* Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks.

Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles

Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
* World Health Organization (WHO) performance status of 0, 1, or 2
* Provided written informed consent

Exclusion Criteria:

* Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
* Received radiotherapy within the past 4 weeks
* History of systemic malignancy other than breast cancer within the previous 3 years
* Estimated survival less than 24 weeks
A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer

The purpose of this study is:

1. To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer
2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways

Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively.

Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted.

A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection.

Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Nil

Exclusion Criteria:

* Nil
Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD

Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites.

The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months.

After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.

Eligibility Criteria:
Inclusion Criteria:

* more or iqual 50 years old
* male or female
* Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
* Greatest linear dimension (GLD) of entire lesion \< 5400 µm (no reading center confirmation required)
* ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
* Total area of lesion must \< 9 MPS DA

Exclusion Criteria:

* pre-treatment
* ETDRS best corrected visual acuity better than 34 letters
* macular surgery history
* laser photocoagulation in the study eye within 30 dais
* eye surgery within 30 days
* history of no-treat glaucoma
* acuite uveits
* history of endophthalmites
* vitreous hemorrhage
* geographic atrophy or fibrosis corresponding \> 50% of the lesion