cyrilzakka/clinical-trials huggingface dataset:
PHIL® Embolic System Pediatric IDE

The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs.

The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.

Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.

Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \<22 years of age
* Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
* Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.

Exclusion Criteria:

* Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
* Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
* Female subject is currently pregnant.
* Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
* Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
* Evidence of active infection at the time of treatment.
* Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
* Subject weighs ≤ 2.5kg Angiographic
* Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
* Contra-indication to DSA, CT scan or MRI/ MRA
* History of intracranial vasospasm not responsive to medical therapy
* Extra-cranial stenosis or parent vessel stenosis \> 50% proximal to the target lesion to be treated.
* Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis
The Effects of Health Coaching for Frequent Attenders

The purpose of the study was to describe and evaluate the effectiveness of health coaching on health-related quality of life, adherence to health regimens, clinical health outcomes and lifestyle factors among frequent attenders in primary healthcare.

The quasi-experimental research method evaluated the effectiveness of health coaching among frequent attenders in primary healthcare. The experimental group received the health coaching and the control group received the usual care. The data were collected with pre- and posttest 12-month follow-up via a questionnaire of FINRISKI2012, RAND-36 and ACDI and clinical health outcomes measured by health-coaching nurses. The data were analyzed by statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had face-to-face visits to the physicians in the local primary healthcare centre at least seven times during a 12-month period
* Aged 18 years or older
* Able to read and understand Finnish

Exclusion Criteria:

* Patients´ visits due to pregnancy or delivery
* Patients´ visits due to serial treatment for the same disease
* An inability to give informed consent
* Involving in another study intervention at the same time
Ultrasound Guided Obturator Nerve Block for Total Knee Replacement (TKR)

Total Knee Replacement can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 yrs
* ASA I - III
* TKR surgery

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurologic deficit in the arm that is going to be operated
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.

This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥ 18 years
* Subjects who are able and willing to provide the informed consent
* Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.

Exclusion Criteria:

* History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.
Effect of Levocarnitine Supplementation for the Management of Fatigue in Levothyroxine-Treated Hypothyroid Patients

It has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms. Carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (ATP) becomes synthesized. Levocarnitine administration reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone replacement. The present study deals with alleviation of fatigue in hypothyroid patients by carnitine supplementation.

It has been well-established now-a-days that, some chronic diseases impose generalized weakness, lethargy, lassitude amounting from degrees mild, moderate to a severe one to total incapacitation on the part of the patients. Hypothyroid patients instate of receiving adequate thyroid hormone replacement, experience fatigue-related symptoms. Carnitine is a non-essential amino acid synthesized endogenously from essential amino acids- lysine and methionine with in the body involved in long chain fatty acid transportation to the mitochondrial membrane. Carnitine- transportation system is essential for production of energy at cellular level. Thyroid hormone plays an important role in carnitine-dependent long chain fatty acid transport and oxidation. Some available reports suggest that, Levocarnitine supplementation produced potentially favourable effects on fatigue-related symptoms in hypothyroid patients although still awaits confirmation. The present study is an attempt to investigate into the effects of Levocarnitine supplementation on fatigue in patients with hypothyroidism.

Eligibility Criteria:
Inclusion Criteria:

i. Clinical diagnosis of primary hypothyroidism patients with fatigue symptoms ii. Age : From 20 to 50 years iii. Levothyroxine treatment: receiving for at least 6 months iv. Serum free thyroxine level: 0.80-1.80 ng/dl v. Serum Thyroid-stimulating hormone level: 0.35-5.50 µIU/ml ( µIU = micro international unit)

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Exclusion Criteria:

i. Patients with Hypothyroidism 20 years and 50 years ii. Acute or chronic liver diseases iii. Anaemia iv. Clinical diagnosis of Diabetes mellitus. v. Cardiovascular disease ( such as heart failure, arrhythmia and uncontrolled hypertension ) vi. Patients with psychological disorders (such as depression, anxiety disorder, schizophrenia, alcoholism or fatigue disorder due to other systemic diseases) vii. Patients having serious infections or terminal illness (such as tuberculosis, HIV or malignant tumor ) viii. Autoimmune diseases ( such as rheumatoid arthritis, Systemic lupus erythematosus or multiple sclerosis) ix. Patients with impaired renal function x. Pregnant or planned to be pregnant xi. Nursing mothers

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TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old and above, male or female;
2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;
3. At least one measurable lesion;
4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
5. A minimum life expectancy of \>3 months;
6. Adequate bone marrow reserve, hepatic, renal, and coagulation function;
7. Other inclusion criteria apply for participating in the Study. -

Exclusion Criteria:

1. Prior anti-HER2 targeting therapy;
2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;
3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;
8. Any active infection which has not been controlled at screening;
9. Other exclusion criteria apply for participating in the Study. -
COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia

The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can cause acute arterial hypoxemia. Treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. The high incidence of disease has also reduced resources needed to safely deliver invasive ventilation including mechanical ventilators and intravenous sedation. Non-invasive respiratory support has been shown to be efficacious in acute hypoxemic respiratory failure from other etiologies and has the potential to reduce rates of intubation and the time spent on mechanical ventilation in COVID-19. However, it is unknown which type of support is the most effective, limiting the ability to improve clinical outcomes and appropriately allocate resources. To help guide clinical practice and policy, it is critical to understand the comparative effectiveness of two forms of non-invasive respiratory support used worldwide, continuous positive airway pressure (CPAP) delivered via a helmet interface and high flow nasal oxygen (HFNO).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed COVID-19 with an Sp02 \< 92% on ≥ 6 liters NC admitted to a Penn Medicine advanced respiratory unit. An advanced respiratory unit is a unit capable of non-invasive respiratory support such as an ICU or intermediate care unit.

Exclusion Criteria:

Patients will be excluded if they meet ≥ 1 of the following criteria based on current Penn Medicine respiratory guidelines and prior trials of non-invasive respiratory support:

* Respiratory failure related to other etiology (e.g. exacerbation of chronic obstructive pulmonary disease, acute pulmonary edema)
* Baseline oxygen requirement
* Diagnosis of acute or chronic hypoventilation
* Tracheostomy
* Claustrophobia
* Prior intubation during hospitalization
* Urgent need for endotracheal intubation
* Other contraindications to non-invasive respiratory support (glasgow coma scale lower than 8, absence of airway protective gag reflex, elevated intracranial pressure, upper airway obstruction)
* Patient dose not wave to receive the assigned intervention.
Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries

Pressure injuries (PIs) pose significant public health concerns, particularly for hospitalized patients with limited mobility. They are one of the five most common causes of harm in healthcare settings, with a global prevalence ranging from 0% to 72.5%. Hospitalized patients face a higher risk of developing PIs compared to those in community settings, with older adults (over 65 years) being particularly vulnerable.

Meta-analysis reveals a global prevalence of PIs at 14.8%, varying significantly across care settings. For instance, in acute care environments, the prevalence ranges from 6% to 18%, highlighting the need for improved preventive measures. A study in the UAE demonstrated that implementing a new intervention protocol reduced the prevalence of PIs from 2% in 2013 to 1.8% in 2018, underscoring that prevention is less costly than treatment.

Furthermore, research indicates that maintaining skin integrity is crucial in preventing PIs, with the Agency for Healthcare Research and Quality emphasizing the use of "Care Bundles" that include comprehensive skin assessments. Topical emollients and products containing hyper-oxygenated fatty acids (HOFAs) are recommended for enhancing skin hydration and reducing PI risk.

Evidence from studies in Gulf countries shows the effectiveness of olive oil in preventing and treating PIs. Despite existing interventions, recent data from the hospital conducting this study revealed a rising incidence of PIs, from 40 cases in 2020 to 55 cases in 2021. This research aims to evaluate the effectiveness of applying extra virgin olive oil topically, alongside standard preventive measures, to reduce the risk of PIs in mobility-compromised patients.


Eligibility Criteria:
Inclusion Criteria:

- mobility-limited stroke, spinal cord injuries, fractures, multiple sclerosis

Exclusion Criteria:

unwilling to participate,
The Effects of Overfeeding on Obesity-Prone (OP) and Obesity-Resistant (OR) Women

This is a longitudinal cohort study of how the responses to a 3 day period of controlled overfeeding relate to subsequent weight gain. We hypothesize that thin individuals are resistant to weight gain because they respond to periods of overfeeding by increasing fat oxidation, reducing food intake, and increasing physical activity relative to those who gain weight over time.


Eligibility Criteria:
* Half of the subjects will be women, half will be men,
* age 25-35,
* a range of BMI's from 19-27, for the 'thin subjects' there should be no 1st degree relatives with a BMI\>30.
* Subjects should not engage in planned physical activity more than 3 hrs per week.
* For the obesity prone group there should be at least 1 1st degree relative with a BMI\>30.
Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)

This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.


Eligibility Criteria:
Inclusion Criteria:

* History of HIV-1 infection confirmed by standard serological tests
* Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
* Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
* Colonoscopy within the past 5 years if ≥ 50 years of age.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Current or past gastrointestinal (GI) medical or surgical conditions
* Use of certain opiate pain medication within 2 weeks of screening
* Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
* CD4 counts \< 100 cells/mm3
* Previous randomization into this study, or into any other crofelemer study
Modified Corneal EA With Middle LKP for Severe Corneal Burn

The purpose of this pilot study is to explore whether modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe corneal burn.


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral severe corneal burn with more than half limbal stem cells deficiency (LSCD). The history of the disease is at least 12 months at the time of screening visit.
2. Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
3. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

1. LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement.
2. LSCD by ocular surface disorders other than ocular burns.
3. Eyelids malposition.
4. The center corneal thickness\<450µm, the depth of corneal opacity\<150µm or the full corneal lamellar opacity.
5. High myopia with a spherical equivalent of -15.0 D or less.
6. Corneal or ocular surface infection within 30 days prior to study entry.
7. Ocular surface malignancy.
8. Uncontrolled diabetes with most recent HgA1c greater than 8.5%.
9. Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m2.
10. Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L.
11. Platelet levels \< 150,000 or \> 450,000 per microliter.
12. Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
13. Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy.
14. Pregnancy (positive test) or lactation.
15. Participation in another simultaneous medical investigation or clinical trial.
16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening.
17. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases.
18. Severe dry eye disease as determined by Schirmer's test \< 2mm at least in one eye.
19. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
20. Signs of current infection, including fever and treatment with antibiotics.