cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism

This multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study consisted of 2 consecutive phases that occurred in the following order: a dose-titration phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed the parent study 990120
* Agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study
* Were able to comprehend and were willing to give written informed consent for participation in the study

Exclusion Criteria:

* Pregnant or breast-feeding
* Had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements
* Had any other condition that reduced the chance of obtaining data (eg, known poor compliance)
* Participating in another investigational study at the time of study entry
* Had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator
Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus of Coronavirus Disease 2019

There is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.The aim was to determine airborne severe acute respiratory syndrome coronavirus transmission, their infectivity in different areas such as patient's room and in medical staff área.

The Corona Virus Disease 2019 is rapidly spreading throughout the world. Aerosol is a potential transmission route.

The transmission of severe acute respiratory syndrome coronavirus in humans is thought to be via at least 3 sources: 1) inhalation of liquid droplets produced by and/or 2) close contact with infected persons and 3) contact with surfaces contaminated with severe acute respiratory syndrome coronavirus. There are many respiratory diseases spread by the airborne route such as tuberculosis, measles and chickenpox. Several studies suggested that airborne spread may have played an important role in the transmission of that disease. At present, there is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.

The aim was to determine airborne severe acute respiratory syndrome coronavirus 2 transmission, their infectivity in in different areas such as patient's room and in medical staff area.

Methods

Cross sectional study of samples from environmental of patient´s room, and medical staff area. Samples will be taken of air using microbial air monitoring systems, and from different surfaces of patient's room and medical staff area, such as computers, mouse and personal protective equipment using cotton swabs. Viral RNA will be determined using Real-Time-Polymerase-Chain Reaction. In positive samples infectiveness will be determined by cell culture under biosecurity conditions.

Statistical analysis will be performed to determine prevalence of positive samples and positive cell culture whit STATA version 15.1.

informed consent will be obtained from all participants

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and more, with diagnoses of COVID-19 96 hours since the beginning of symptoms.
* Medical staff, nurses and/or physician taking care of patient whit COVID-19

Exclusion Criteria:

* Unwilling to give informed consent
A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects

This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
* Male between 18 to 55 years of age (extremes included), on the date of signing the ICF.
* A Body Mass Index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x the upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered nonclinically significant in the opinion of the investigator.

Exclusion Criteria:

* Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
* Known contraindication or hypersensitivity to interferon-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part).
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
* Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)

The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.
* The LRTI cohorts should also fulfill the following criteria:

  * Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 7 days (AND)
  * Symptoms duration ≤7 days (AND)
  * Clinical suspicion of LRTI or pneumonia

Exclusion Criteria:

* Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days
* Another episode of an acute infection during the last 2 weeks
* Congenital immune deficiency (CID)
* A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
* Active malignancy
* Pregnancy
* Current treatment with immune-suppressive or immune-modulating therapies including without limitations:

  * Use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the past two weeks
  * Monoclonal antibodies
  * Intravenous immunoglobulin (IVIG)
  * Cyclosporine, Cyclophosphamide, Tacrolimus
  * Granulocyte/Monocyte colony stimulating factor (G/GM-CSF)
  * Anti-Tumor Necrosis Factor (TNF) agents
  * Interferon (of all kinds)
* Other severe illnesses that affect life expectancy and quality of life such as:

  * Moderate to severe psychomotor retardation
  * Post-transplant patients (including solid organs, allogeneic/autologous stem cell transplantation)
  * Moderate to severe congenital metabolic disorder
Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery

The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs.

Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.


Eligibility Criteria:
Inclusion criteria

1. non-cancerous and cancerous pathology
2. signed Consent
3. Every patient operated on a scheduled or emergency abdominal surgery

Exclusion criteria

1. inability to give informed about information
2. minor Patient
Emergence Agitation of Sevoflurane in Pediatric

Low dose nalbuphine versus dexmedetomidine on prevention of emergence agitation in children

The incidence of emergence agitation (EA) varies between 18% and 80.

EA occurs most frequently in preschool children during the early stage of emergence from anaesthesia .

It is considered a potentially serious postoperative complication that can result in physical harm and removal of intravenous catheters. As such, EA is a source of dissatisfaction for the parents of paediatric patients and their healthcare providers .

Sevoflurane is an inhalational anaesthetic used widely as a paediatric or outpatient anaesthesia due to its excellent hemodynamic stability and low blood solubility, which allows rapid induction and emergence from general anaesthesia, as well as control of the depth of anaesthesia. However, when sevoflurane is used alone it is associated with a higher incidence of emergence agitation in children. The rapid removal of residual anaesthetics due to low blood solubility of sevoflurane has been suggested to cause emergence agitation in some patients

Nalbuphine is a semi-synthetic, agonist antagonist opioid analgesic agent that acts as a partial agonist at kappa receptors and an antagonist at µ receptors, has minimal side effects, and exhibits a ceiling effect for respiratory depression .

Nalbuphine should effectively relieve postoperative pain and decrease the rate of EA in paediatric patients after sevoflurane anaesthesia.

Dexmedetomidine, a selective alpha 2 agonist, has been shown to reduce the incidence of postoperative agitation with sevoflurane anaesthesia .

Dexmedetomidine can affect the brain and spinal cord α 2-adrenergic receptor, inhibition of neural discharge to produce sedative, analgesic, and anxiolytic effects.

The Locus Coeruleus is a verified key part of the brain responsible for the regulation of arousal and sleep. Dexmedetomidine affects the brainstem locus coeruleus α 2-adrenergic receptors and produces sedative, hypnotic, and anxiolytic effects and it has also anesthetic-sparing effects without significant respiratory depression .

This study will be conducted to evaluate the effect of intravenous nalbuphine IV 0.1 mg/kg versus Dexmedetomidine IV 0.5 μg/kg on EA in paediatric patients undergoing ENT surgeries under sevoflurane anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 - 10 years.
* Sex: male and female
* Patients with ASA classification I and II

Exclusion Criteria:

* Refusal of the caregiver to give written informed consent.
* History of allergy to the medications used in the study.
* psychiatric disorder.
* ASA classification III - IV.
* Fever, cough, asthma or upper respiratory tract infection.
* surgery more than 2 hours
* Hearing defect that limits communication.
* Neurological disorder .
* History of malignant hyperthermia.
* surgeries more than 2 hours.
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.

Patients harbouring rectal adenocarcinoma T3-4 or N\>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients before and after CRT, after surgery and during follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1.

Exclusion Criteria:

Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent.

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A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* colon or rectal cancer, with metastases;
* \>=1 measurable lesion.

Exclusion Criteria:

* previous systemic treatment for advanced disease;
* radiotherapy to any site within 4 weeks before study;
* daily aspirin (\>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
* co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
Study of Male Osteoporosis and Aging

The aim of this study is to identify potential risk factors for fragility fractures in men.

Osteoporosis is a disease characterized by decreased bone mass and pathological changes in the microarchitecture of the bones. The clinical significance of osteoporosis is the association with fragility fractures and, consequently, increases in both morbidity and mortality.

In men, genetical and life-style factors are known to affect the risk of fractures, however, data relating these factors with measures of bone mineral density and fracture risk are limited.

30.000 men aged 60-70 were randomly selected from the Central Office of Civil Registration in Denmark. Each receive a questionnaire addressing demographics, potential risk factors of osteoporosis, past medical history and medication by mail. In case of consent, the participants will complete a full medical examination including DXA and sampling of DNA if they have a fragility fracture. At the same time, 2 participants from the study population will be selected as control. The study period is 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 60-70 being able to consent in writing
Combine GELOX With Concurrent Radiation Therapy for Patients With Stage IE/IIE ENKTL

To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed stage IE/IIE ENKTL.

1. Patients

   * All patients should sign a written informed consent form before enrollment, and the study should be approved by the Sun Yat-sen University Cancer Center Ethics Board.
   * Baseline of patients: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional). Epstein-Barr virus (E B V) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD 25) in the serum.
   * Recheck before and after every course: Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD25) in the serum.
   * Recheck every two course: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional)
2. Treatment Protocol - The GELOX regimen consist of the following drugs: gemcitabine ：1250 mg/ m2 on days 1,ivdrip oxaliplatin ：85 mg/m2 on day 1, ivdrip pegaspargase : 2500 IU/m 2 daily on day 1,intramuscular The treatment cycle was repeated every 14 days.

   * IFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions, we define the clinical target volume of limited stage IE disease as the bilateral nasal cavity, bilateral ethmoid sinuses, and ipsilateral maxillary sinus; and the clinical target volume would extend to involved tissues for patients who had extensive stage IE disease. For patients who had stage IIE disease, the clinical target volume also, included the bilateral cervical lymph node area.

     * Disease Progression during the treatment should be treated with second-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ENKTL
* age:18-69years
* Ann Arbor stage IE,or stage IIE with cervical lymph node involvement
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
* primary lesion not from the upper respiratory
Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.

A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :

availability in a majority of ED, delay, cost and irradiation, in particular In young patients.

Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.

The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .

120 patients will be enrolled on CAP suspicion. All explorations (radiography...) and biological exams (blood culture...) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured Primary Purpose: diagnostic Study Phase: Not Applicable Intervention Model: NA Number of Arms: 1 Masking: open label, Masked Roles: NA Allocation: NA Study Endpoint Classification: efficacy Enrollment: 120 subjects (anticipated )

Eligibility Criteria:
Inclusion Criteria :

- clinical suspicion of PAC

Exclusion Criteria :

* documented end-of-life
* pregnancy
* seriously ill patients
Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers

30 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.

Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
2. Acceptable medical history, physical examination and laboratory tests during screening
3. Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

1. History of clinically significant disease
2. Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
3. Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin \> 1.5 times of normal upper limit
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 months prior to the first dosing