cyrilzakka/clinical-trials huggingface dataset:
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
* Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation in the study eye
* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
* GA in either eye due to causes other than AMD
* Diabetic retinopathy in either eye
* Active or history of wet AMD in either eye
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
* Active malignancy or history of malignancy within the past 5 years
* Previous participation in any studies of investigational drugs within 3 months preceding Day 0
Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.

PRIMARY OBJECTIVES:

I. To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy (EGD).

After completion of study, patients with serious adverse events are followed up until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

Eligibility Criteria:
Inclusion Criteria:

* Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
* Patients can provide informed consent
* Patients have no known coagulopathy and no known history of esophageal varices

Exclusion Criteria:

* Patients are not undergoing clinically indicated EGD
* Patients have known coagulopathies or history of esophageal varices
* Patients do not have the ability to give informed consent
An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan

This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.

Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.

The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.

The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.

Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with any solid tumor and genome profiling results

Exclusion Criteria:

* None
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)

A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 18 and 35
* Woman who are able to become pregnant must use an acceptable form of birth control

Exclusion Criteria:

* You are breast feeding
* You have taken any type of pain reliever within 12 hours of electrostimulation
* You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
* You have muscle atrophy, weakness or neuromuscular disorder
Clinical Algorithm for Post-Stroke Gait Training With C-Brace

The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Diagnosis of hemiparesis or hemiplegia following stroke
* Presence of abnormal walking pattern
* Poor knee control during stance phase
* Cognitive ability to (or care provider) manage daily charging of battery
* Cognitive ability to follow commands
* Hip flexor muscle strength grade 3 or greater or the ability to perform reciprocal gait using compensatory patterns

Exclusion Criteria:

* Weight \> 275 lbs. (Includes body weight and weight of heaviest object carried)
* Less than 2° of ankle motion
* Severe spasticity of the quadriceps (MAS \>3) and/or uncontrolled spasticity of the quadriceps
* Severe spasticity of other lower limb muscles (MAS \>3)
* Fixed genuvalgum exceeding 10° beyond anatomic neutral valgum
* Any fixed genuvarum exceeding anatomic neutral varum.
* Hip or knee flexion contractures greater than 10°
* Presence of chronic obstructive pulmonary disease (COPD)
* Chronic heart failure - New York Heart Association (NYHA) stages 3 and 4
Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

It is estimated that epistaxis results in 4.5 million emergency department visits per year throughout the United States. Due to the adverse effects of standard treatment options for epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies, when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer for patients with epistaxis who present to the emergency department.

This is a prospective, randomized, single-center, double-blinded, placebo controlled study comparing efficacy and safety of topical intranasal tranexamic acid for epistaxis. The primary outcome was time to control of bleeding and secondary outcomes were length of stay in the emergency department, re-bleeding within the first 24 hours, and re-bleeding at one week. Safety outcomes were the incidence of thromboembolic events and other drug-related adverse events.

Patients aged 18 years of age or older and diagnosed with anterior epistaxis were included. Patients were excluded if they were unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication.

Patients were randomly assigned to tranexamic acid treatment group or placebo group. After consenting, patients received TXA (100 mg/1mL) or 0.9% sodium chloride (1 mL) in to the affected nostril(s) via intranasal atomization device. If bleeding did not cease, two repeat doses were allowed and after twenty minutes of continued bleeding the study physician could treat with any additional treatment options. Patients were contacted via telephone within one week to inquire about incidences of re-bleeding or any complications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with anterior epistaxis

Exclusion Criteria:

* Unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication
The ShortCut™ Study Protocol

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
* Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.

Exclusion Criteria:

* An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
* Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability.
* Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
* Hemodynamic or respiratory instability.
* Left ventricle ejection fraction \< 30%.
* Ongoing severe infection, sepsis or endocarditis.
* Renal insufficiency
* Need for emergency surgery for any reason.
* Life expectancy is less than 1 year.
Upwards Laryngeal Handshake Technique and Simple Palpation for Locating the Cricoid Cartilage

This study aims to compare upwards laryngeal handshake technique and simple palpation for locating the cricoid cartilage.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia

Exclusion Criteria:

* History of neck surgery
* Anatomical anomaly or skin lesion in the neck
* History of gastroesophageal reflux disease
BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.

Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem cells are isolated and cultured from umbilical cord tissues.

30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines, which would be used as the control group.

Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.

The primary endpoint is to assess the improvement of patient's C-peptid and HOMA-β, HOMA-IR, cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.

Eligibility Criteria:
Inclusion Criteria:

* Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more
* Patients are able to read, write and understand ICF form and agree to participate in the study
* Males and females between age 18 and 70 years at the screening.
* FBG \> 7 mmol/L
* 8% ≤ HbA1C ≤ 11%
* Fasting C-peptide \> 0.6 ng/ml
* Anti GAD (-)
* The patient is treated by two oral diabetes medications but uncontrolled blood glucose (HbA1C ≥ 8%)

Exclusion Criteria:

* Pregnant women, planning to become pregnant and lactating women during the study period
* The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease;
* Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO;
* Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia
* Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days
* Hematologic disease or coagulopathy
* There are abnormalities in liver function (AST and/or ALT ≥ 2 times or bilirubin ≥ 2.0 times normal value at the time of screening);
* Patients with immunodeficiency diseases such as HIV or hepatitis B and C;
* Acute or chronic pancreatitis or a history of acute pancreatitis;
* Patients taking immunosuppressive drugs (such as azathioprine, methotrexate) within 6 months before the study time or taking immunosuppressive drugs;
* The patient is unable to complete the study;
* The patient is participating in another study.
A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride

An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.

This is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy volunteers with two sessions (I and II). Each session consists of a run-in day for baseline assessments, 13 treatment days and 5 additional days for assessments. Subjects will be randomized to start with either the prucalopride or placebo session.

Between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any carry-over effect.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 45 years, extremes included.
2. Subject has a normal weight as defined by a Quetelet Index range of 18 - 30 kg/m2, extremes included.
3. Informed consent form signed and dated, prior to screening.
4. Healthy on the basis of a pre-trial physical examination, medical history, anamnesis, electrocardiogram, 24 hour Holter monitoring and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomization.

Exclusion Criteria:

1. History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse.
2. Smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection.
3. History of cardiac arrhythmia's, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis, Parkinsonism, drug allergy.
4. Presence of prolonged QTc (Bazett) on ECG at screening (QTc \> 450 msec in male subjects, QTc \> 470 msec in female subjects).
5. Use of concomitant medication, except for oral contraceptives and paracetamol. All other medication must have been stopped at least 14 days before the first dose.
6. Participation in an investigational drug trial in 30 days prior to the first visit.
7. Donation of blood in the 60 days preceding the first visit.
8. Pregnancy (as confirmed by a HCG test during screening and at day 0 of each treatment session) or breast-feeding female.
9. Subjects with positive results for HIV, hepatitis B or C at screening.
10. Female subjects of childbearing potential without adequate contraceptive protection during the trial.
The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion, serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each subject will be generated. Using correlation analysis, we will compare between microbial compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be collected from patients and cultured to test antibiotic resistance.


Eligibility Criteria:
Inclusion otitis media with effusion,parental informed consent, age between 1 - 9 years, no known immune deficient disorder -

Exclusion Criteria:no parental consent, known immune disorder, current acute otitis media.

-
Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction

The purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

Anthocyanins, a subclass of flavonoids, are plant pigments that provide the rich color of many plants, fruits, and flowers. Health benefits of anthocyanins have been widely reported in the research literature, particularly for disease conditions associated with oxidative stress, such as cardiovascular and neurodegenerative diseases. Emerging evidence suggests that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health conditions. Maqui berries (Aristotelia chilensis), indigenous to Chile, have one of the highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin in maqui berries is delphinidin. Delphinidin is more bioavailable than most flavonoids, with intact molecules absorbed in appreciable amounts in less than an hour after consumption. Systemic effects of delphinidin include reduced inflammation due to downregulation of NF-kB, the transcription factor that initiates the generation of pro-inflammatory cytokines. The omega-3 fatty acid eicosapentaenoic acid \[EPA\], a component of omega-3 fatty acid concentrates, also has anti-inflammatory properties. There is much empirical evidence demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in inflammation. It has been demonstrated the dietary supplementation with EPA-rich marine oil concentrations reduces cytokine levels up to 15%.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 50-85 years old
* Generally healthy, non-smoker
* Able to provide informed consent
* BMI: 30-40 kg/m2

Exclusion Criteria:

* Existing auto-immune conditions
* Use of warfarin or other blood thinners
* Use of anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy
* Individuals engaged in vigorous exercise (\>2 x 30 min/week), vegetarians, and people who routinely take multivitamins or herbal supplements.
Project MARS: Mobile-Assistance for Regulating Smoking

This study aims to identify states of vulnerability for lapse, identify states of receptivity for engaging in self-regulatory activities, and investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.

Aim 1: Identify states of vulnerability for lapse: Self-reported and sensor-based measures will be used to identify empirically-based and theoretically-grounded features across multiple time scales that are most predictive of lapse. Operationalizing vulnerability in terms of the predicted level of risk for lapse, the investigators hypothesize that (H1) current vulnerability is represented by current and/or recent high negative emotions, low positive emotions, high craving, low self-efficacy, low self-regulatory capacity (SRC), and risky context (e.g., specific locations, such as a bar; cigarettes available; others smoking).

Aim 2: Identify states of receptivity for engaging in self-regulatory activities: Self-reported and sensor-based measures will be used to identify empirically-based and theoretically-grounded features across multiple time scales that are most predictive of engagement (i.e., usage of self-regulatory activities). Operationalizing receptivity in terms of the predicted likelihood of engagement, the investigators hypothesize that (H2) current receptivity is represented by high positive activating emotions (e.g., happy, grateful), low negative deactivating emotions (e.g., sad, boredom), low craving, high self-efficacy, high SRC, and low risk contexts (e.g., specific locations, such as home).

Aim 3: Investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts. Investigate whether, what type, and under what conditions (e.g., current state of vulnerability and/or receptivity) a prompt to engage the individual in self-regulatory activities increases engagement, hence reduces vulnerability.

The proposed research will help build a comprehensive conceptual, technical, and empirical foundation necessary to develop effective Just-in-Time-Adaptive-Interventions (JITAIs) based on dynamic models of vulnerability and receptivity. In the micro-randomized trial (MRT), Ecological momentary assessments (EMAs) are administered before and after JITAIs with items that are designed to measure different indices that may be related to participants' engagement of the JITAIs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Current smoker with an average of at least 3 cigarettes/day
* Motivated to quit within the next 30 days
* Valid home address
* Functioning telephone number
* Can speak, read, and write in English
* At least marginal health literacy (as determined by 45 or greater on REALM literacy test)

Exclusion Criteria:

* Contraindication for nicotine patch
* Current use of tobacco cessation medications or other aids (i.e. buproprion)
* Pregnancy or lactation (as self-reported)