cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy

The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, between 18 and 70 years of age.
2. Patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-ASA derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study .
3. Presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum (up to 15 cm proximal to the anus).
4. Patients with mild to moderate active ulcerative colitis, as defined by the DAI ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤ 12.
5. Women with negative serum test for pregnancy.
6. Women of childbearing potential provided they use adequate contraceptive precautions during the treatment period. Adequate contraceptive methods are defined as those with a failure rate \<1% per year when correctly used, and include implants, injectables, combined oral pills, some IUDs or a vasectomised partner in a stable relationship.
7. Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.

Exclusion Criteria:

1. Presence of other clinically significant medical condition as determined by the Investigator.
2. History of hypersensitivity or idiosyncratic reaction to heparins.
3. History of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction.
4. Presence of arterial hypertension (SAP ≥ 160 mm Hg; DAP ≥ 95 mm Hg).
5. Receipt of any investigational agent within 90 days of starting treatment.
6. Use of rectal 5-ASAs or rectal corticosteroids within 2 weeks before the starting the study.
7. Use of anti-TNF agents or immunosuppressive drugs such as azothioprine, 6-mercaptopurine or cyclosporine A in the last 3 months.
8. Patients with ulcerative colitis of severe entity (DAI \> 10 or CAI \> 12), or with limited distal ulcerative proctitis, or with infectious colitis confirmed by microbiological assessment in stool.
9. Patients with severe intestinal bleeding, or with Hb \< 9 g/dL.
10. Presence of significant hepatic impairment (AST, ALT \> 2 ULN).
11. Presence of significant renal impairment (creatinine \> 2 ULN).
12. Women who are pregnant or who are breast feeding.
13. Intestinal obstruction.
14. Presence of type 1 or type 2 diabetes.
15. Concomitant oral antibiotic treatment, within 2 weeks before starting the study.
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants

The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin)
* Participants who are overtly healthy males or females, as determined by medical history and physical examination

Exclusion Criteria:

* Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing
* Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food
* women who are lactating
* Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis
Model-informed Precision Dosing for Linezolid

Study Rationale: Previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations (between 2 and 7 mg/L) achieve clinical efficacy and microbiological eradication while minimizing side effects like thrombocytopenia and the emergence of resistance. No prospective or randomized clinical trial has confirmed these findings, and there is no consensus on how to adjust linezolid dosing to achieve optimal drug concentrations.

Objectives: The primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose. Secondary objectives include assessing the PK/PD profile, investigating the prevalence of linezolid resistance among gram-positive bacteria, assessing microbiological resolution of infection, and evaluating the safety and tolerability of linezolid.

Methodology: This study is an open, monocentric pilot randomized controlled trial with two arms: standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and PK/PD targets developed in TMDx software.

Sample Size: 28 patients, 14 in each group. Assumptions are based on only 25% of patients in intensive care achieving the optimal therapeutic range with standard dosing, compared to an expected 80% achieving this with model-informed precision dosing.

Selection Criteria: Adult patients (18+ years) already starting linezolid treatment for gram-positive infections, expected to require treatment beyond the next calendar day. Exclusions include imminent death, expected or confirmed pregnancy, expected linezolid treatment of less than 4 days or more than 4 weeks.

Outcomes: The primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mg/L on Day 7 and Day 13.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each
3. with written informed consent of the patient or
4. with written informed consent of his/her legal representative or
5. after using the option of inclusion via spouse according to § 1358 BGB or
6. after application of the independent consultant procedure
7. Patients of childbearing age: negative pregnancy test

Exclusion Criteria:

1. Patients receiving antibiotics active against Gram-positive bacteria at the same time of linezolid
2. Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis
3. Death is deemed imminent and inevitable
4. Pregnancy
5. Lactation/breastfeeding
Systane® Complete Preservative Free Lubricant Eye Drops

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.

Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete the Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to understand and sign an informed consent form
* Subject with mild to moderate dry eye
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 3 months prior to screening.
* Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
* Other protocol-defined exclusion criteria may apply
FTIH of ECC5004 in Healthy and Diabetic Participants

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus

This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 300mg, and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 10mg to 150mg to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients with Type 2 Diabetes Mellitus

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants of non-childbearing potential
* Age of 18 to 65 years
* BMI of 18.0 to 32.0 kg/m2
* Hemoglobin A1c ≤ 6.0%
* Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence
* Male participants agree to use contraception, or agree to practice true abstinence
* No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history
* Able to understand and sign and date informed consent

Additional Inclusion Criteria for Part 2 (MAD)

* Diagnosed Type 2 Diabetes Mellitus of 18 to 70 years of age inclusive
* Type 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment
* BMI of 24.0 to 40.0 kg/m2 with a minimum body weight of 50.0 kg (110 lbs)
* HbA1c ≥ 7.0% and ≤ 10.5%, and fasting plasma glucose ≤ 270 mg/dL
* Blood pressure (BP) with or without medication: Systolic BP ≤ 160 mmHg, AND Diastolic BP ≤ 100 mmHg
* Not taking any active treatment regimen

Exclusion Criteria:

* Concomitant participation in any investigational study of any nature
* Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing
* Unable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatment
* Serum calcitonin \> 20 ng/L
* Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
* Diagnosis of T1DM or secondary forms of diabetes
* Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
* History of pancreatitis
* Significant allergic reaction to active ingredients or excipients of the study drug.
* Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.

PRIMARY OBJECTIVE:

I. To determine the efficacy of focal therapy for treatment of prostate cancer.

SECONDARY OBJECTIVES:

I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year.

II. To assess safety.

OUTLINE:

Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign an informed consent form
* Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
* Patients ≥ 18 years of age at time of consent
* Life expectancy ≥ 5 years
* Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study

Exclusion Criteria:

* Nodal or distant metastases
* Prior treatment for prostate cancer
* Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
* Known contraindications to general anesthesia
* Uncorrectable coagulopathy
* Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction
* Any condition that would prohibit the understanding or rendering of informed consent
* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia

This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period. After the Treatment Period subjects will be followed for a one-month treatment free period.


Eligibility Criteria:
Inclusion Criteria:

* Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
* Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
* Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).

Exclusion Criteria:

* Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
* Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
* Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).
Safety Study in Adolescent and Adult Patients With Asthma

E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
* Male and female asthma patients aged 12 - 75 years
* Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment
* No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
* Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter
* Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study

Exclusion Criteria:

* A smoking history of 10-pack years, or having smoked within 12 months of screening
* Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma
* Concurrent clinically significant diseases
* Known intolerance or hypersensitivity to any component of the study drugs
* Recent infection of the respiratory tract, before screening
* Use of prohibited medications
* Having been on other investigational drug/device studies in the last 30 days prior to screening
* Known or highly suspected substance abuse
Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years.

* Imagery analysis
* Questionnaires

The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Treated with one of the described procedures

Exclusion Criteria:

* Evaluation material present
Inappropriate Sinus Tachycardia Registry

The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
2. Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements

Exclusion Criteria:

1. Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
2. Subject with exclusion criteria required by FDA or local governance
Nursing Homes Study of Fall Risk Assessment Oriented to Intervention

The aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes.

Falls are the most frequent accidents in nursing homes, affecting more than a third of residents each year. Up to 10% of fallers require hospitalization or suffer a fracture. Psychological consequences affects between 20 and 80% of fallers, which suffer a lack of self-confidence that leads to reduction of activities and an increase of the dependence in activities of daily living.

Not all the residents have the same risk, and each person can have more than one risk factor that can be identified (previous falls, self confidence, weakness, gait disorders, dizziness, cognitive impairment, etc).

Identification of risk factors is the first step to reduce falls, but is not enough by itself. For this reason, interventions directed towards the correction of identified risk factors are required. In this setting, multifactorial interventions are the most successful to reduce falls numbers and its consequences.

As individual randomization of residents presents important inconveniences (group contamination, control arm residents could felt discriminated), we will randomized nursing homes to each group.

Eligibility Criteria:
Inclusion Criteria:

* People with or without cognitive impairment living indefinitely in a nursing home place
* Able to walk with or without any kind of help or able to self transfer (as defined in category d420 of the WHO International Classification of Functioning, Disability and Health) without help
* Give their consent (or the legal guardian in case of cognitive impairment).

Exclusion Criteria:

* Terminal illness (expected death before 6 months).
* Occupying temporarily a nursing home place (convalescence period) or another kind of place(day center, long term care, etc).
Evaluation of Two Different Thickening Products in Patients With Dysphagia

Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care. Diet modification with thickening agents is an essential aspect of this nutritional support. The purpose of this investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based thickening agent (Thickenup Advance or TUA).

Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.

Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. The investigators hypothesize that alterations in food taste (sweet, salty, etc...), viscosity will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.

Eligibility Criteria:
Inclusion Criteria:

* History of dysphagia necessitating a dynamic fluoroscopic swallow study
* Age \> 18 years
* Ability to complete a comprehensive dynamic fluoroscopic swallow study
* Ability to provide informed consent for study participation

Exclusion Criteria:

* Age \< 18 years
* Pregnant women
* Prisoner or other institutionalized individual
* Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study