cyrilzakka/clinical-trials huggingface dataset:
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers

The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.

This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or females, 19-60 years of age (inclusive).
2. Medically healthy with no clinically significant screening results.
3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
4. Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated.
2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
3. Normal clinical laboratory values.
4. Normal heart rate and blood pressure.
5. Blood donation or significant blood loss within 56 days prior to dosing.
6. Plasma donation within 7 days prior to dosing.
7. Participation in another clinical trial within 28 days prior to dosing.
Effect of HFNO Therapy on Respiratory Effort After Extubation

Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation.

Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.

Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies.

Study population: Adult patients on invasive mechanical ventilation (IMV) for \>72 hours, who are scheduled for extubation.

Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation.

Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Receiving IMV \> 48 hours for any cause
* Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
* Provided written informed consent, through legal representatives on indication

Exclusion Criteria:

* Any clinical situation preventing appropriate execution of study procedures
* The presence of a tracheostomy
* Any feature that precludes HFNO-initiation
* Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
* Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
* Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing)
* Known pregnancy or current breast-feeding
Postoperative Analgesia After Total Hip Replacement

There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.

VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.

Eligibility Criteria:
Inclusion Criteria:

* Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower

Exclusion Criteria:

* Not able to speak dutch
* communication problems
* dementia
* mental retardation
Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.

Eligibility Criteria:
Inclusion Criteria:

* children undergoing ophthalmologic surgery with general anesthesia
* children aged 1 - 12 years old
* physical status ASA 1-2
* signing informed consent

Exclusion Criteria:

* children undergoing emergency surgery
* children with PICU nursing after surgery
* children with psychological and neurological condition
* children with allergic history to dexmedetomidine and midazolam
* children with history of malignant hyperthermia or family history of malignant hyperthermia
* children with possibility of difficult intubation and ventilation
How to Provide Vascular Control of Splenic Artery Aneurysm? Report of Two Cases

Spleen artery aneurysm represents the most common visceral aneurysm and the third most common splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other diagnostic focuses and examinations. The investigators present two patients with splenic artery aneurysms localized in the splenic hilum, who auspiciously undergo laparoscopic splenectomies with hem-o-lock clips in the vascular hilum without complications. These two cases showed that in addition to the numerous advantages of minimally invasive approaches, there is the possibility to improve laparoscopic technique in terms of safety and economic reasons by using hem - o - lock clips as a hemostatic technique securing the vascular elements of the splenic hilum.


Eligibility Criteria:
Inclusion Criteria:

Adults patients (\>18 year old) with splenic arterial aneurysms

Exclusion Criteria:

Patients younger than 18 years old. Patients without splenic arterial aneurysms
Comparison of Colonoscopy and Sigmoidoscopy in Terms of Pain, Acceptance and Procedure Time

According to experience in a self-payed health check-up center,unsedated total colonoscopy is not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients' acceptance.

Hypothesis: Unsedated total colonoscopy is not inferior to unsedated sigmoidoscopy in terms of pain and patients' acceptance.

According to American Cancer Society guideline, screening total colonoscopy every 10 years or sigmoidoscopy every 5 years is recommended for average risk people above 50 years old. However,study in Taiwanese population demonstrated that 37.8% of colorectal lesions were beyond reach of sigmoidoscope, and in cases with lesions with advanced pathology, 66.7% did not have distal colorectal lesion. However, many people think colonoscopy is more painful and choose sigmoidoscopy for screening. However, according to experience in a self-payed health check-up center,unsedated total colonoscopy is not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients' acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who undergo self-payed unsedated colonoscopy or sigmoidoscopy for colon cancer screening.

Exclusion Criteria:

* Difficulty in assessing pain during the procedure and acceptance for the procedure
Mechanisms of Massage

The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. The researchers aim to extend these findings by understanding the influence of expectation on these findings.

Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established. In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia. Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant. Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.

Eligibility Criteria:
Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* non-English speaking
* systemic medical condition known to affect sensation (i.e. diabetes)
* regular use of prescription pain medication to manage pain
* current or history of chronic pain condition
* currently using blood thinning medication
* any blood clotting disorder such as hemophilia
Drug Use Investigation of Kaletra

This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.


Eligibility Criteria:
Inclusion Criteria:

* All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.

Exclusion Criteria:

* Contraindications according to the Package Insert:

  * Patients with a history of hypersensitivity to any ingredient of Kaletra
  * Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.

The efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.

Continous epidural injection will be done during 10 days N group will be injected a 0.19% ropivacaine 8mL only every other day during 10 days

Eligibility Criteria:
Inclusion Criteria:

* Patients who has herpes zoster
* Patients has a period (at least 1month) after onset of herpes zoster
* Patients has a definite symptom along dermatome
* ASA class I - II
* Age : 18 - 80 years

Exclusion Criteria:

* Patients who has a cancer
* Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease
* Patients who has a other dermatologic disease
* Patients who has major operation \& procedure history
* Patients who has a other pain origin
* Patients who can not be inserted epidural catheter
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study

To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.

Sorafenib (Soranib Tablet) will be administered orally at a dose of 600mg daily without food for patients who have been treated with prior systemic therapy for advanced HCC. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent, or study closure.

Response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either CT scan or MRI.

After the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Age of 20 or more
3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center
4. Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies
5. Intolerant to or progressed on at least 1 prior systemic treatment for HCC
6. Having at least one measurable target lesion (per RECIST v1.1)

   - Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
7. Child-Pugh class A or B7
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
9. Life expectancy of at least 16 weeks
10. Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment):
11. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.

Exclusion Criteria:

1. Fibrolamellar carcinoma or sarcomatoid carcinoma
2. Having active brain metastasis or leptomeningeal metastasis
3. Moderate to severe or intractable ascites
4. Presence of hepatic encephalopathy
5. Presence of active bacterial infection
6. Uncontrolled severe medical comorbidity
7. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
8. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).

This is a multicenter, open-label, blind-end, randomized controlled trial at 5 hospitals in Shanghai, China. The KD children diagnosed within 14 days of onset according to the diagnostic criteria for KD released by American Heart Association (AHA) in 2017 will be considered for participants in the trial. The patients meeting eligibility criteria will be randomly assigned in a 1:1 ratio to the control group (receiving 2 g/kg\*1 IVIG and 30 mg/kg/d aspirin) or intervention group (receiving 2 g/kg\*1 IVIG, 30 mg/kg/d aspirin and additional 5 mg/kg\*1 infliximab) based on the randomly block design (block sizes 4). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, other clinical manifestations, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at least 7 timepoints: at admission, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after onset of KD to assess the coronary artery lesions.

Eligibility Criteria:
Inclusion Criteria:

* Meeting diagnostic criteria for KD released by American Heart Association (AHA) in 2017, including complete KD (also sometimes referred to as typical or classic KD) and incomplete KD ((also sometimes referred to as atypical KD);
* Diagnosed within 14 days of illness (including the 14th day, considering the first day of illness as the first day of fever);
* Not treated with IVIG or other treatments for KD yet;
* Z score of any coronary artery of LMCA, LAD, LCX, the proximal and middle segment of RCA ≥ 2 calculated based on the height, weight and coronary artery diameter measured by echocardiography;
* Aged between one month and 14 years.

Exclusion Criteria:

* Receiving steroids or other immunosuppressive agents in the previous 30 days;
* With a previous history of KD;
* Afebrile and all the inflammation indicators (including white blood cell count, CRP, and erythrocyte sedimentation) become normal before enrolment;
* With suspected infectious diseases including tuberculosis, sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, influenza, EBV infection, etc;
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities;
* Unable to be followed up for at least 1 year.
Autonomous Blood Drawing Optimization and Performance Testing

The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).

The study consists of several phases (A, B1, B2, C1, C2, 0).

Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing.

Phases A, B2, C1, C2 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection).

The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers is included in a non-hospital site (Vitestro Site).


Eligibility Criteria:
Inclusion Criteria:

• Age ≥16 years.

Exclusion Criteria:

* Unable to follow instructions, due to mental disability and/or incapacity
* Unable to use device correctly due to physical impairment or disability (for example a patient with severe contractures or deformities)
* No venipuncture possible in cubital fossa of both arms (for example: after amputation of both arms)
* No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms)
* Incapacitated persons
* Pregnant or breast-feeding

The following contra-indications / exclusion criteria are respected per arm:

* Arteriovenous fistula or vascular graft
* Paretic or paralyzed arm (e.g. after stroke or trauma)
* Infected skin in cubital fossa (for example: erysipelas or cellulitis)
* Mastectomy side, axillary lymph node excised
* Healed skin burns in cubital fossa
* Edema in cubital fossa
* Extensive scarring in cubital fossa
* Hematoma in cubital fossa
* Tattoos in cubital fossa

In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2, a manual venipuncture and automated venipuncture are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 study.
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) \> 200.

Exclusion Criteria:

* Acute respiratory distress syndrome (ARDS)
* Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
* Long QT syndrome
* Prolonged baseline QTc interval (≥450 ms).
* Cardiogenic shock or severe hypotension (SBP\< 90 mmHg)
* Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
* Severe sinus - node dysfunction with marked sinus bradycardia
* 2nd/3rd degree heart block
* Bradycardia without pacemaker that has caused syncope
* History of severe dysthyroidism
* A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)