cyrilzakka/clinical-trials huggingface dataset:
Safety Study of MG1102 in Patients With Solid Tumors

To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in patients with solid tumors for which no standard therapy is available.

This is an open-label, Dose Escalation Study, multicenter phase I study to evaluate the safety and tolerability, determine the pharmacokinetics, and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor.

Each subject will receive on dose of MG1102 followed by a 6-day rest period. If the initial dose is tolerated, subject will continue with the 21 days of MG1102 administration (5 days on treatment, 2 days off treatment for 3 weeks.) Subjects that have a tumor response as stable disease, may continue therapy on a compassionate use.

Study Duration : for a minimum of 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Solid tumors refractory to conventional therapy or the subject does not tolerate the conventional therapy
* Evaluable disease or at least one measurable tumor mass by a radiographic technique
* Life expectancy ≥3 months
* Suitable for intravenous administration of study medication
* Signed written informed consent
* Adequate bone marrow, renal, and liver function
* Coagulation profile with aPTT and INR, each ≤ 1.5 x ULN
* No evidence of active Hepatitis B or Hepatitis C infection
* Proteinuria \<100 mg
* ECOG performance status ≤2
* Female subjects must agree to use contraceptive measures
* Negative serum ß-hCG
* Ability and willingness to comply with the study protocol

Exclusion Criteria:

* Pregnant or lactating women
* Therapy with systemic anticoagulant or antithrombotic agentswithin 7 days prior to first dose
* Hemoptysis within 3 months prior to first dose
* Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to first dose
* Surgery or visceral biopsy within 28 days prior to first dose
* Minor surgical procedure performed within 7 days prior to first dose
* Prior exposure to MG1102
* Known history of HIV
* With active bacterial infections and/or receiving systemic antibiotics
* Current or past diagnosis of leukemia
* Known CNS metastases or clinical evidence of CNS
* Non-healing wound within past 2 weeks
* Bleeding diathesis or bleeding within 14 days prior to enrollment
* Clinically significant thrombosis
* Non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease
* History of idiopathic or hereditary angioedema
* History of sickle cell or any hemolytic anemia
* Require hemoglobin, WBC, or platelet transfusion support or use of hematopoietic growth factors within 2 weeks prior to entry
* Uncontrolled hypertension
* History of clinically significant renal disease
* History of significant medical illness of cardiac or CNS disease within the past 6 months
* Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
* Medical or psychiatric illness
* Recreational substance use or psychiatric illness
* Known hypersensitivity to MG1102 or components of the formulation
LUX Lung Special Access Scheme Australia Named Patient Use (NPU)

The program will provide early access to the investigational drug BIBW 2992 to treat patients with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety and efficacy information on BIBW 2992 use.

Named Patient Use (NPU)


Eligibility Criteria:
Inclusion criteria:

* Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with pleural effusion or Stage IV

Exclusion criteria:

* Brain metastases which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four 4 weeks without the requirement for steroids or anti epileptic therapy
* Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
* History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3)
* Cardiac left ventricular function with resting ejection fraction of less than 50%
* Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent)
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) three times the upper limit of normal (if related to liver metastases five times the upper limit of normal)
* Serum creatinine 1.5 times of the upper normal limit or calculated/measured creatine clearance 45ml/min
* Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
* Pregnancy or breast feeding
* Patients unable to comply with the protocol
* Patients with known HIV, active hepatitis B or active hepatitis C
* Pre-existing Interstitial Lung Disease (ILD)
* Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.2.1.
* Patients already pre-treated with BIBW 2992
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS

Exclusion Criteria:

* Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (\< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12.

Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.

This international multicentric prospective study is an observational study that will include consecutive SLE patients treated with HCQ and with SLE flare (defined by the SELENA-SLEDAI flare composite). The study will only require the sampling of 1 vial of whole blood for the dosage of HCQ (that would be centralized and performed in PITIE-SALPETRIERE Hospital at the completion of the study). The patients and the physicians will also have adherence self-questionnaires to complete, and the physicians will complete a patient data sheet.

The end points are adherence of the treatment in the whole group, and subgroups, adherence according to the severity of SLE, and the relationship between patient's questionnaires, physician evaluation of adherence and blood HCQ dosage.

If investigators confirm their previous data, this study might demonstrate that a significant proportion of patient candidates for treatment escalation are in fact nonadherent to the treatment. It might further demonstrate the interest of HCQ concentrations monitoring, both in "real life" and in therapeutic study in SLE as it may avoid unnecessary, expensive or even hazardous regimen escalation.

Eligibility Criteria:
Inclusion criteria :

* History of meeting 4 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus including a positive test for antinuclear antibodies,
* SLE flare defined by the SELENA-SLEDAI flare composite
* Treatment with HCQ for at least 2 months with a daily dosage \> or equal to 200 mg/day.

Exclusion criteria :

* Patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)
A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
* Melanoma
* Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
* Gastric adenocarcinoma (includes gastro-esophageal junction)
* Hepatocellular carcinoma (HCC)
* Squamous cell carcinoma of the head and neck (SCCHN)
* Renal cell carcinoma (RCC)
* Bladder cancer
* Participants must have received available standard therapies
* Women and men must agree to follow instructions for method of contraception
* Measureable disease as per RECIST version 1.1 criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Participants must not have active brain metastases or leptomeningeal metastases
* Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
* History of allergy or hypersensitivity to study drug components
* Participants with serious or uncontrolled cardiovascular disease
* Excluding patients with serious or uncontrolled medical disorders
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
* Participants with an active, known, or suspected autoimmune disease
* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Other protocol defined inclusion/exclusion Criteria could apply
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (ICF) prior to any trial-related procedures
2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
3. Subject at least 18 years of age
4. Female subjects must be of either:

   1. Non-childbearing potential, or,
   2. Childbearing potential, provided there is a confirmed negative urine pregnancy test
5. Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index \< 1%)

Exclusion Criteria:

1. Location of the selected treatment area:

   * on the periorbital skin
   * on the perioral skin/around the nostrils
   * within 5 cm of an incompletely healed wound
   * within 10 cm of a suspected BCC or SCC or other neoplasia
2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
6. Organ transplant recipients
7. Immunosuppressed subjects (for example HIV patients)
8. Female subjects who are breastfeeding.
9. Subjects who are institutionalised by court order or by the local authority
10. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Sequential Endoscopic Lung Volume Reduction

Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.

Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Eligibility Criteria:
Inclusion Criteria:

* Heterogenous emphysema
* FEV1 \< 45%
* RV \> 150%
* TLC \> 100%
* TLCO \< 40%

Exclusion Criteria:

* Homogeneous emphysema
* Pregnancy
* PCO2 \> 50 mmHg
Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children

To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma


Eligibility Criteria:
Inclusion Criteria:

* Boys or girls between 3 and 6 years old
* Presenting to emergency departments with an acute asthmatic attack
* Requiring nebulised bronchodilator therapy
* Rint increased by 200 % compared to theoretical Rint
* Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)

Exclusion Criteria:

* Ipratropium bromide received within four hours before admission
* First acute asthmatic attack
* Hospital admission to intensive care with asthma within six months before inclusion
* Hospital admission for asthma during the month prior to inclusion
* Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
* Concomitant cardiac disease
* Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma
* Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients
* Renal or hepatic insufficiency
* Poorly controlled diabetes
* Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial
* Past history of lung surgery
* Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis
* Patients unable to follow with protocol or correctly undergo the evaluations
* Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial
* Previous participation in this trial
MR Images Variation With or Without Denture Wear

The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Eligibility Criteria:
Inclusion Criteria:

* dentulous
* edentulous classified Eichner' s classfication

Exclusion Criteria:

* involuntary motion occurs during imaging
* absolutely contraindicated or as a rule contraindicated of MRI examination
* subjects have ferromagnetic metals in the oral cavity
* subjects can not swallow naturally
Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia

The present study will investigate variations in acid base equilibrium caused by the administration of four different crystalloids with increasing strong ion difference (0.9% saline, Ringer's lactate, Ringer's acetate, plasmalyte-like solution) in patients during general anesthesia.

The same crystalloid will be administered throughout the surgery. In order to assess the effect of hemodilution, every patient will receive two fluid boli with different volumes of the same solution. pH and strong ion variations, togher with the renal response to acid base disturbances, will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (between 18 and 75 years old);
* ASA (American Society of Anesthesiologists) physical status classification system 1 or 2;
* Patients undergoing spinal surgery under general anesthesia, intubated and mechanically ventilated;
* Normal preoperative albumin;
* Surgery with an estimated duration of at least 3 hours.

Exclusion Criteria:

* Patients who are pregnant;
* Patients with obesity (BMI \> 35);
* Patients with a chronic obstructive pulmonary disease (COPD);
* Patients with obstructive sleep apnea (OSA) treated with CPAP;
* Patients with chronic heart failure (CHF) with a NYHA (New York Heart Association) class ≥2;
* Patients receiving diuretics in the pre-operative period;
* Patients with a chronic kidney disease (CKD), defined as a GFR \< 60 ml/min/1.73 m2;
* Patients with diabetes mellitus treated with insulin;
* Patients with myopathies; Patients undergoing a surgery with likely fluid losses or with unexpected bleeding during surgery.
Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients with Acute Ischemic Stroke

According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.

Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.

Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation. The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.

According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.

Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.

Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation.The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset

Exclusion Criteria:

* Patients transported to hospitals via emergency medical service
* Patients with in-hospital stroke