cyrilzakka/clinical-trials huggingface dataset:
Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma

To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).

In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of esophageal squamous cell carcinoma;
* At least one measurable lesion (by RECIST1.1);
* Patients who have failed to a chemoradiation treatment;
* 18-75，ECOG PS:0-1,Life expectancy of more than 12 weeks;
* No treated with molecular targeted drugs;
* Main organs function is normal;
* Patients should participate in the study voluntarily and sign informed consent;

Exclusion Criteria:

* Allergic to anlotinib and/or its excipients;
* Patients with any severe and/or unable to control diseases，including：

  1. Blood pressure unable to be controlled ideally(systolic pressure \>140 mmHg，diastolic pressure\>90 mmHg);
  2. Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male， QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF\<50%;
* Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
* Patients with a bleeding tendency and INR\>1.5,APTT\>1.5 ULN ;
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.);
* Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage;
* Patients treated with VEGFR inhibitor;
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
* Patients participated in other anticancer drug clinical trials within 4 weeks;
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;
Colloidal Silver, Treatment of COVID-19

Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.

Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities I

Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.

Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities Infectious diseases account for more than 20% of global mortality and viruses are responsible for about one-third of these deaths. Highly infectious viral diseases such as severe acute respiratory (SARS), Middle East respiratory syndrome (MERS) and coronavirus disease (COVID-19) are emerging more frequently and their worldwide spread poses a serious threat to human health and the global economy.

The current COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) .

Eligibility Criteria:
Inclusion Criteria:

* Inclusion of any patient, over the age of 18, consulting the Sahloul emergencies, Sousse for symptoms of COVID -19 dating less than 10 days and having a positive COVID-19 on the PCR test and typical scanner.

Exclusion Criteria:

* Any pregnant or breastfeeding woman
* patient with an expectation of survival of less than 24 hours
* Dyspnea leading to heart failure
* Hepatic insufficiency
* Chronic respiratory failure
* Renal failure, clearance \<20ml • min-1 • 1.73 • m-²
A Natural History Study of Participants With Potassium Sodium-Activated Channel Subfamily T Member 1 (KCNT1)-Related Epilepsy

The primary objective of the study is to characterize seizures in participants with KCNT1-related epilepsy. The secondary objectives are to characterize head growth, symptom severity, neurocognitive and social functions, adaptive behavior, sleep, quality of life, caregiver burden, and mood in participants with KCNT1-related epilepsy.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have clinically and genetically confirmed diagnosis of KCNT1-related epilepsy provided by the investigator. For purposes of this study, mutations that are genetically confirmed to cause KCNT1-related epilepsy are defined to specifically exclude known benign variants (e.g., distal C terminus, splice site, etc.).
* Willingness of the participant and/or the participant's legally authorized representative (LAR) to comply with scheduled visits and study procedures.

Key Exclusion Criteria:

* Any condition that may interfere with the assessment of KCNT1-related epilepsy and that is clearly not related to this disease (in the judgment of the investigator).
* History of human immunodeficiency virus infection.
* History of central nervous system (CNS) tumors or malignancies, including CNS metastatic disease.
* Current enrollment or past enrollment in an interventional clinical study in which an investigational gene therapy is/was administered.
* Enrollment in an interventional clinical study in which an investigational small molecule, antibody or antisense oligonucleotide (ASO) treatment or approved small molecule, antibody or ASO therapy for investigational use is administered within 1 month (or 5 half-lives of study agent, whichever is longer) prior to the screening visit.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?

Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may be incorporated as a prevention strategy for lowering the risk of AD. However, fish intake seems not to protect APOE4 carriers from developing AD. One explanation as to why APOE4 carriers may not benefit from fish intake is potentially linked with imbalances in omega-3 fatty acid metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6 weeks, increases in the two fatty acids was less for carriers resulting in a significant gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate the fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein concentrations which has the consequence to be associated with imbalances in EPA and DHA transport. The investigators will recruit and test 100 healthy young adults since at older ages carriers of ApoE4 usually take medication altering their lipoprotein profile. They will receive an EPA + DHA supplement for one month. This period was chosen because the 3 class of lipoproteins (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and cholesteryl esters and to fully investigate lipoprotein fatty acid changes, one month of supplementation is needed to change EPA and DHA in all lipid classes. The investigators will monitor the distribution of EPA and DHA in the lipoproteins over a one month supplementation with fish oil and the investigators will separate the investigators groups by APOE4 carriers and non-carriers.


Eligibility Criteria:
Inclusion Criteria:

* Fifty healthy men and fifty healthy women aged between 20-35 y old will be recruited.

Exclusion Criteria:

* Tobacco
* Medication (except for oral contraceptives)
* EPA+DHA supplements
* Cancer
* Recent major surgery (\< 2 years)
* Ongoing or past severe drug or alcohol abuse
* History of psychiatric difficulties or depression
* Allergy to seafood
* Elite level of physical training
* Pregnancy and breastfeeding
Impact of NOL Intraoperative Guided Fentanyl Analgesia vs SCC for Elective Major Abdominal Surgery

Recently, a newly developed index, the Nociceptive Level (NOL) index, was validated and showed superiority over heart rate and blood pressure for recognition and grading of intense and mild nociceptive stimuli during surgery under general anesthesia.

We hypothesize that compared with standard management, NOL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia, to increased hemodynamic stability.

Uncontrolled postoperative pain may result in significant clinical, psychological, and socioeconomics consequences. Not only does inadequate pain management following surgery result in increased morbidity and mortality but it also may delay recovery, result in unanticipated readmissions, decrease patient satisfaction, and lead to chronic persistent postsurgical pain. Pain is multifactorial in nature and understanding both the complexity of pain and its side effects is imperative to achieve a successful surgical outcome.

Nociception/analgesia are currently assessed by monitoring changes in heart rate (HR), blood pressure (BP), and other indirect parameters which are not sensitive or specific to nociception. As a result, the patient may be given insufficient analgesia which can promote postoperative pain, or excessive analgesia which can result in overdosing and related complications.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. ASA I-III
3. Elective major laparoscopic abdominal surgical, urologic or gynecologic procedures under general anesthesia.
4. Patient able to provide informed consent

Exclusion Criteria:

1. Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block)
2. Patients with rhythm other than sinus cardiac rhythm, implanted pacemakers, α2-adrenergic agonists and β1-adrenergic antagonists
3. Pregnancy/lactation
4. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
5. Abuse of alcohol or illicit drugs within the last 6 months
6. Chronic pain conditions - pain in 1 or more anatomic regions that persists or recurs for longer than 3 months and is associated with significant emotional distress or significant functional disability.
7. Opioid tolerant - if for at least 1 week the patient has been receiving oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hour; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; or an equianalgesic dose of any other opioid
8. Chronic use of psychoactive drugs within 90 days prior to surgery
9. Allergy or intolerance to any of the study drugs
10. History of severe cardiac arrhythmias within the last 12 months
A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening
* Have a prior or planned surgical treatment for obesity
* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
* Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had within the past 90 days before screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * hospitalization for unstable angina, or
  * hospitalization due to congestive heart failure
* Have New York Heart Association Functional Classification Class IV congestive heart failure
* Have a history of chronic or acute pancreatitis
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health

This research aims to evaluate the effect of anodic oxidation of implant abutment collar on the peri-implant soft tissue health.

A randomized controlled clinical trial will be implemented on 10 implant abutments in five patients, each having 2 dental implants in the same quadrant. Abutments with standard silver collars will be divided into two groups: Group 1 (test group) will undergo anodic oxidation of the abutment collar changing it into pink color. Group 2 (control group) untreated abutments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients with good oral hygiene.
* Having two inserted dental implants in the same quadrant with healing abutments.
* Implants with at least 1 mm peri-implant soft tissue height.

Exclusion Criteria:

* Patients with systemic conditions interfering with soft tissue health.
* Heavy smoking.
* Patients with inflamed gingival tissue or bad oral hygiene.
* Diseased gingival tissue that needs periodontal treatment.
Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

Primary objective:

* Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

* ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
* Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

The total duration per subject is 8-9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Fed period: 7 days including 5 treatment days
* Washout: at least 14 days after last dosing
* Fasted period: 7 days including 5 treatment days
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion Criteria:

Healthy male subjects:

* as determined by medical history, physical examination including vital signs and clinical laboratory tests
* with a body weight between 50kg and 95 kg and a Body Mass Index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Any contraindication to clopidogrel
* Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).


Eligibility Criteria:
Inclusion Criteria:

* Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
* Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;

Exclusion Criteria:

* Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
* Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
* Persons with severe peripheral nerve injury gap length \> 10 cm in length;
* Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
* Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
* Presence of disease that might interfere with participant
Vitamin K2 and Muscle Weakness in Type 2 Diabetes

The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed type 2 diabetes.
* Age \>/= 40 years
* No changes in anti-diabetic medication in the last 3 months.
* Muscle weakness (grip strength \<27kg and females \<16kg)

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* Cancer or cancer that has been in remission \<5 years
* Any medical condition that prevents participants from exercising safely
* On anticoagulant therapy
* Currently consuming vitamin K2 supplements
* Current smoker
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery

The purpose of this study is to determine the relationship between intraocular pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comply with the study procedures

  * 18-80 years old
  * Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \> 22 mmHg at the screening visit and under ocular hypotensive treatment.
  * Subject has consented to be in the trial
  * Visual acuity of 20/200 or better
  * Presence of cataract requiring phacoemulsification with lens exchange
  * Ability to understand the character and individual consequences of the study
  * For women of childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects presenting with any of the following criteria will not be included in the trial:

  * Subjects with contraindications for wearing contact lenses
  * Severe dry eye syndrome
  * Keratoconus or other corneal abnormality
  * Conjunctival or intraocular inflammation
  * Eye surgery prior to and throughout the study.
  * Full frame metal glasses during SENSIMED Triggerfish® monitoring
  * Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
  * Pregnancy and lactation
  * Simultaneous participation in other clinical studies
Alleviant ALLAY-HF Study

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*

   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
   2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT

Exclusion Criteria:

1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction
Preparation Protocol for the First Pediatric Dental Visit

To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit

The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).

Eligibility Criteria:
Inclusion Criteria:

* child requiring a first dental visit

Exclusion Criteria:

* previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address
To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)

The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD criteria, will participate in the study.The study will consist of 2 steps as indicated below; starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. In each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. In addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COPD, 40 to 80 years of age
* All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator 30% \</= Forced Expiratory Volume (FEV1) \</= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) \<70%.

Exclusion Criteria:

* Patients with a significant respiratory disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator
* Patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability
* Patients with a history of CF
* Patients with clinically evident bronchiectasis
* Patients with a history of asthma
* Patients who have undergone thoracotomy with pulmonary resection
* Patients with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease