cyrilzakka/clinical-trials huggingface dataset:
COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

Few data are available on the management of critically ill pregnant women with pneumonia related to SARS-CoV-2. In the absence of clear recommendations for the management of delivery, clinicians are faced with the risk of pregnancy continuation against the risk of premature birth. In these multicenter retrospective study, the investigators want to describe clinicians attitude on delivery management in pregnant women requiring invasive mechanical ventilation for acute respiratory distress syndrome related to SARS-CoV-2.

Two strategies will be compared on maternal, obstetric and neonatal outcomes:

* Wait strategy defined by no extraction within 24 hours of invasive venting
* Early strategy defined by extraction within 24 hours of invasive ventin


Eligibility Criteria:
1. patient \> 18 years
2. Patient with SARS-CoV-2 pneumonia proven by RT-PCR
3. Hospitalization in an intensive care unit during pregnancy after 14 weeks' gestation
4. Need for ventilatory support including: oxygen therapy \> 6L/min and/or NIV and/or High Flow Oxygen and/or invasive mechanical ventilation +/- ECMO.

Exclusion Criteria:

* Patient's refusal to participate in this study
Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from drivers suspected of driving under the influence. In this study, the investigators aim to correlate zopiclone serum concentrations with degrees of driving impairment in healthy volunteers by use of a validated driving simulator. The investigators also aim to compare their results with the results from a previous study that investigated zopiclone impairment of cognitive and psychometric tests.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Caucasian ethnicity
* Age 25-35 years
* Possession of a driver's licence for at least five years

Exclusion Criteria:

* Score ≥ 2 on the modified Apfel-scale to assess risk for motion sickness(\*)
* History of driving under the influence of alcohol and/or illicit substances
* History or presence of alcohol or illicit drug abuse
* Former abnormal reaction to any hypnotic drug
* History of strong averse reactions to blood sampling procedures
* Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort)
* History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators
* Detection of any drugs of abuse on pre-session urine drug screening

(\*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting:

1. Smoker? yes 0, no 1
2. History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1
3. History of car sickness after 10 years of age? yes 0, no 1

A score of two or more points excludes participation.
Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
2. Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
3. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

1. Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
2. Known HIV, chronic hepatitis B, or hepatitis C infection.
3. Known concomitant infection which would require additional systemic antibiotics.
4. Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
5. Current use of corticosteroid drugs or other immunosuppressive therapy.
6. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
7. Known significant renal, hepatic, or hematologic impairment.
8. History of intolerance or hypersensitivity to macrolide antibiotics.
9. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy \<30 days).
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study

Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India


Eligibility Criteria:
Inclusion Criteria:

Positive for any one or more of the following:

* All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)
* Clinical signs/symptoms (non-healing ulcers, white/ red/red \& white patches in the mouth, restriction of mouth opening and swelling of the neck)
* All individuals aged above 40 irrespective of habit/oral lesions

Exclusion Criteria:

* Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer
* Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders
The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters

Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed up by Acıbadem Hospital Organ Transplantation Center
* Patients accepted to participate in the study
* Older than 18 years of age
* ASA class III
* MELD score \>12
* Scheduled for elective liver transplantation surgery from a living donor

Exclusion Criteria:

* Patients undergoing re-transplantation
* Under the age of 18 years
* Patients undergoing emergency surgery
* Patients with hepatorenal or hepatopulmonary syndrome
* Patients receiving mechanical ventilation support in the ICU
* Patients refusing to participate
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

Primary:

* To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
* To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

* To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetic patients
* Measure HbA1c 6.5% to 11.0% at visit 1
* More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

* Pregnant women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.

The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).


Eligibility Criteria:
Key Inclusion Criteria (Part 1):

* Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.
* No more than 3 prior anticancer regimens for advanced disease.
* Measurable or evaluable, nonmeasurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Able to take and retain oral medications.
* Additional criteria exist.

Key Exclusion Criteria (Part 1):

* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
* Treatment with prior chemotherapy within 21 days of first dose of study drug.
* Requiring IV alimentation.
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
* History of being unable to tolerate gemcitabine or any of its components.
* Additional criteria exist.
Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study

The study aims to evaluate the feasibility of using Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* 21-75 years old
* smoke ≥10 cigarettes per day
* mild to moderate distress (K10 scores 10-35)
* access to a reliable internet connection
* all prescription medications stable for ≥ 1 month prior to enrollment and throughout the trial, and approved by the Study Physician

Exclusion Criteria:

* Current suicidal ideation
* Current use of smoking cessation medication (e.g., varenicline)
* Current use of inhaled products (other than cigarettes) which may influence exhaled carbon monoxide measures (e.g. smoking cannabis, vaping)
* History of seizure disorder, recent (\<5 years) seizure history, cerebrovascular accident, neurodegenerative disease, or traumatic brain injury
* Currently receiving chemotherapy or radiation
* Presence of metal objects in the head/neck
* Any skin disorder or skin sensitive area near stimulation locations
PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.

Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.

Eligibility Criteria:
Inclusion Criteria:

Preoperative MRI with degeneration grades\<III at the 1st supradjacent lumbar segment.

Exclusion Criteria:

* Body mass index≥40kg/m\*m
* Severe osteoporosis
* Lumbar fracture
* Preoperative SVA\>4cm
* Spondylolisthesis grades\>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation
Evaluation of the Accuracy of the Masimo Pulse-Hemoglobin-Meter Monitor in Surgical Patients

This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas analysis and the Masimo Continuous Hemoglobin Monitor

The chief objective of this study is to internally validate the accuracy of the Masimo SpHb (TM) technology as compared to our laboratory measurement of Hb. We have been using the Masimo SpHb monitor on patients who underwent open heart surgery, hepatic resection, kidney transplant and aortic aneurysm repair since January 2009. These patients also had hemoglobin concentration measurements as part of the arterial blood gas analysis performed by our laboratory to evaluate intraoperative ventilation and electrolyte changes. We will collate the laboratory measurements with the Masimo SpHb values documented in the anesthetic records.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had indwelling arterial catheters placed for surgeries that involved major blood loss and who had serial hemoglobin concentration measurements for their surgeries, since January 2009. This will represent approximately 50 patients.

Exclusion Criteria:

* Inclusion criteria are patients undergoing major surgery from January 2009 - April 2009, who had continuous hemoglobin pulse oximetry readings form the Masimo SpHb monitor and serial hemoglobin concentration measurement from the lab. Patient who did not have these studies will be excluded.
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

* Known central nervous system leukemia
* Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
* History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
* Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients. The subjects were randomly divided into two groups according to 1:1, with about 304 subjects in the experimental group and the control group.

This study was a randomized, double-blind, active-controlled, multicenter Phase 3 clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative.608 patients would be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and control group. Subjects will be stratified by pathological type: squamous cell carcinoma versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male versus female. After randomization, subjects will be treated according to the randomization results.

Eligibility Criteria:
Inclusion Criteria:

1. Be≥18 to ≤ 75 years of age at enrollment, male or female.
2. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
3. No EGFR sensitive mutations or ALK gene translocation alterations.
4. Capable of providing fresh or archived 2 years' tissue samples collected at post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1 testing with TPS \< 1% .
5. Have a life expectancy of at least 3 months.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. No prior systemic therapy for advanced or metastatic NSCLC was received.

Exclusion Criteria:

1. Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies, etc.), and immune cell therapy.
2. Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose.
3. Presence or history of any active autoimmune disease, including, but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism.
4. Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose;
5. Palliative radiotherapy completed 7 days prior to first dose.
6. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening.
7. Clinically significant cardiovascular or cerebrovascular disease

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Revefenacin in Acute Respiratory Insufficiency in COPD

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Objective: To assess the efficacy of nebulized revefenacin in improving the lung mechanics of COPD patients with acute respiratory failure requiring invasive mechanical ventilation (MV), in comparison to a control group receiving the short-acting muscarinic antagonist ipratropium.

Hypothesis: Revefenacin is as efficacious as ipratropium in improving the lung mechanics of COPD patients with acute respiratory failure.

Study Design:

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 40 years of age
* Acute respiratory failure requiring invasive mechanical ventilation
* Documented history of COPD based on spirometric evidence of FEV1/FVC\<70%
* Smoking history \>10 years (current or prior)
* Invasive mechanical ventilation for \< 96 hours

Exclusion Criteria:

* Chronic invasive mechanical ventilation via tracheostomy. Patients with tracheostomy alone without chronic mechanical ventilation may be enrolled.
* Expected duration of mechanical ventilation \<24 hours
* Hypersensitivity to muscarinic antagonists
* Inability to tolerate albuterol
* Lack of documented COPD history
* For patients taking short- or long-acting muscarinic antagonists (SAMAs or LAMAs) at the time of screening, inability or unwillingness to undergo the SAMA or LAMA washout period (6 hours or 24 hours, respectively) prior to initiating study drug.
* Presence of ARDS or acute congestive heart failure
* Unwillingness or inability to remain on the study drug with for the duration of the study
* Unwillingness or inability to have open-label muscarinic antagonists withheld for duration of the study
* Unwillingness or inability to utilize the Puritan-Bennett 980 (PB980) ventilator
* Pulmonary comorbidities such as pneumothorax or pneumomediastinum that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
* Documented restrictive lung disease or history of interstitial lung disease
* Actual body weight exceeding 1 kg per centimeter of height
* Pregnancy
* AST or ALT \> 3 times the upper limit of normal, or other clinically significant acute or chronic liver disease
* Known history of glaucoma
* Enrollment in other interventional clinical trial
* Moribund patient not expected to survive \>24 hours
* Decision to withhold life-sustaining treatment, except in those patients committed to full support except cardiopulmonary resuscitation
* Inability to obtain informed consent from patient or legally authorized representative (LAR)
Antihypertensive Effect of Simvastatin in Hypertensive Patients

Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.

The purpose of this study is to determine the effect of Simvastatin on the blood pressure

This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients with controlled or uncontrolled blood pressure

Exclusion Criteria:

* Secondary causes of hypertension;
* Systolic Blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg
* Complain of side effects related to Statins
* Diabetes
* Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
* Renal disease (creatinine \> 1,5 mgdl).