cyrilzakka/clinical-trials huggingface dataset:
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.

After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.

Eligibility Criteria:
Key Inclusion Criteria:

* Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
* Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
* DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal
* FVC ≥ 45% of predicted normal

Key Exclusion Criteria:

* Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1)
* Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
* Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
* Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
* Cardiovascular diseases, any of the following:

  * Uncontrolled hypertension, within 3 months of Visit 1
  * Myocardial infarction within 6 months of Visit 1
  * Unstable cardiac angina within 6 months of Visit 1
* Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer

The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with squamous cell carcinoma of the oral cavity.
* Patients aged between 18 and 80 years.
* Patients who are to receive one of the following treatment
* Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment.
* Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive.
* Patients who voluntarily express their intention to participate by informed consent.

Exclusion Criteria:

* Patients who denied informed consent.
* Patients who have hypersensitivity or allergy to any of the components included in the study.
* Patients diagnosed with HIV, and autoimmune diseases.
Biobank Clinical Genetics Maastricht (KG01)

Collection of coded biomaterial and clinical data with patients consent for future research.

Collection of coded biomaterial and clinical data with patients consent for future research, with the purpose to indentify new gene mutation and prossibilities for treatment in the future.

Eligibility Criteria:
Inclusion Criteria:

* New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital
* Withdrawal of body material for genetic diagnostics.

Exclusion Criteria:

* Patient does not understand the Dutch language.
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants

The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days.
* Birth weight less or equal to 1500 g
* Minimum enteral intake of 150-160 mL/kg/d fortified HM
* Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry

Exclusion Criteria:

* Infants with weight z-score \< -2 SD, based on the Fenton growth chart (Fenton 2013)
* Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia.
* Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine.
* Cholestasis (total bilirubin \> 5 mg/dL or 85 umol/L and direct bilirubin \> 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT).
* Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.).
* Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.).
* Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,:

  * NEC grade above or equal to 2
  * Uncontrolled sepsis
* Suspected or documented maternal substance abuse:

  * Born to mothers who smoked \> 10 cigarettes per day during pregnancy
  * Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
* Subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
* Infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.

Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years,
* Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection).
* Evidence of pulmonary involvement on CT scan or X-Ray of the chest,
* Symptom onset within the previous 10 days AND at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) \>50 years, 3) obesity (BMI\>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of \>35mg/L, 7) oxygen saturation at rest in ambient air of \<94%

Exclusion Criteria:

* Contraindications to the class of drugs under study (C1 esterase inhibitor);
* History or suspicion of allergy to rabbits;
* Women who are of childbearing potential and not using methods of contraception during the entire study period;
* Pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening;
* Chronic liver disease (any Child-Pugh score B or C);
* Currently admitted to an ICU or expected admission within the next 24 hours; and
* Currently receiving invasive or non-invasive ventilation
TARGeted Intraoperative radioTherapy (TARGIT) Registry Database

This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. This study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. The aim is to confirm the long-term effectiveness and safety of the technique.

Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.

Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria.

Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally.

Eligibility Criteria:
Inclusion Criteria:

* Recommended treatment by MDT
* Consent has been obtained to have patient data to be collected

Exclusion Criteria:

* Pregnancy (females who have a positive pregnancy test prior to surgery)
* Under 18 years of age
A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject is implanted with one of the study IOL models between 3 and 5 years previously.
* Subject follow-up is expected to be possible during the duration of the study.
* Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
* Documented medical history and required pre-operative baseline information is available for retrospective data collection.

Key Exclusion Criteria:

* Subject is participating in a separate investigational drug or device study.
* Pregnancy at the time of enrollment.
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-\<32 week and 32-\<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies.

In vitro studies with azithromycin show good inhibitory activity against U. urealyticum. Pharmacokinetic studies of azithromycin in older children show better tolerance, higher tissue concentration, fewer side effects, and fewer drug interactions, when compared to erythromycin. Thus far, there have been no published data on the pharmacokinetic profile of azithromycin in neonates including low birth weight infants. However, the clinical pharmacology profile suggests a substantial therapeutic advantage of this drug in the newborn. To date, there are no data on the PK profile of IV Azithromycin from whence rational dosing can be derived.

Eligibility Criteria:
Inclusion Criteria:

1. 24 to 37 weeks gestational age
2. postnatal age 0 to 30 days
3. May require therapy with antibiotics/anti-infectives
4. Have baseline Hematology labs available (hemoglobin, hematocrit, white blood cell and differential and platelet count), which have been obtained within the previous 72 hours, as part of their standard of care
5. Signed informed consent by the parent or guardian

Exclusion Criteria:

1. Clinically significant hepatic disease (ALT or AST twice the normal value)
2. Clinically significant anemia (hemoglobin \< 10 gm %)
3. Neutropenia (absolute neutrophil count \< 500 cells/mm3)
4. Clinically significant renal disease \[Creatinine clearance twice the normal value, as calculated by the Schwartz formula : Length in cms x k (a constant) / S.Cr (Values for the constant are given in Appendix 1)\]
5. Cardiac rhythm abnormalities
6. Critically ill patients
7. Patients who are on or expected to be on the following concurrent medications carbamazepine, phenytoin, theophylline, digoxin, warfarin, ergot alkaloids, triazolam, cyclosporine, terfenadine, hexobarbital and antacids.
Nerve Transfers to Restore Hand Function in Spinal Cord Injury

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.

Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury.
* Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).
* Finger flexor and extensor strength should be ≤ MRC 1 strength.
* Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.
* Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.
* Ability to comply and participate in rigorous post-surgical therapy regimen.

Exclusion Criteria:

* Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.
* Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose \<300 mg / m2), using a cryoprotection has never been assessed.

The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample.

By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus.

The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.


Eligibility Criteria:
Inclusion Criteria:

* upper age to 18 years
* mammary adenocarcinoma nonmetastatic and histologically proven
* wait under an adjuvant or neoadjuvant chemotherapy according to the following conventional scheme: 3 cycles of F5-Fluorouracil, epirubicin and cyclophosphamide 100 (500 or 5-Fluorouracil 600 mg / m² J1, Epirubicin 100 mg / m² J1, Cyclophosphamide 500 or 600 mg / m² J1 or 3 cycles of Epiribucin and Cyclophosphamide 100) followed by 3 cycles of docetaxel, 100 mg / m², +/- trastuzumab if Her2+++
* Patient with the capacity/faculties to understand a newsletter and sign an informed consent
* Patient receiving social coverage
* Patient who can be treated and followed in the center for a period of at least one year
* WHO scale 0 or 1

Exclusion Criteria:

* Age below 18 years
* Diseases of the scalp or whatever hair-showing against helmet or alopecia
* Using pre nail resin before and per chemotherapy
* mammary adenocarcinoma stage IV
* Indication of docetaxel for cancer of another organ than breast
* Treatment processing or programmed during chemotherapy with an innovative molecule being evaluated
* Raynaud's syndrome, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia.
* Uncontrolled severe arterial disease.
* Presence of a device\> grade 1 neuropathy before the start of chemotherapy
* Patient unable to submit the protocol followed for psychological, social, family or geographical
* Patient with an incompatible underlying disease or concomitant with the inclusion in the trial, whether psychiatric or somatic
* Patient trust, guardianship, under legal protection measure, deprived of freedom
* Male
* Criteria for non randomization (before the first course of docetaxel) :

  * Presence of peripheral neuropathy\> grade 1 after the first 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.
  * Presence of a nail or skin toxicity\> grade 1 after 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.
Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery

RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery.

PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery.

OBJECTIVES:

Primary

* Determine whether whole blood thrombin generation assay (WBTGA) detects hypercoagulability in patients with metastatic carcinoma compared with a healthy control group.
* Determine whether results of the WBTGA will change as a result of major surgery performed on patients with metastatic carcinoma.
* Establish a reference interval for the WBTGA using healthy controls.

Secondary

* Compare a battery of plasma components known to affect or reflect coagulant or fibrinolytic reactions in patients with metastatic carcinoma vs healthy controls.
* Establish reference intervals for this battery of tests using healthy controls.
* Determine how major surgery in cancer patients affects this battery of factors.
* Identify changes in these factors that correlate with changes in the WBTGA.
* Compare the results of WBTGA tests in patients who develop venous thromboembolism (VTE) with those who do not.

OUTLINE: This is a pilot study.

Blood samples of patients are collected on day -7 and day 1 after surgery.

Blood samples of healthy controls are collected once.

After collection, blood samples are analyzed for hypercoagulability by whole blood thrombin generation assay. Routine blood tests are performed, as are immunoenzyme techniques for antigenic tissue plasminogen activator and its inhibitor, thrombin-antithrombin complexes, tissue factor, factor VIIa, D-dimer, and glycocalicin.

PROJECTED ACCRUAL: A total of 30 patients and 30 healthy controls will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients meeting the following criteria:

  * Diagnosis of metastatic carcinoma
  * Must be enrolled in 1 of the following surgical protocols:

    * NCI-99-C-0123
    * NCI-00-C-0069
    * NCI-03-C-0085
    * NCI-03-C-0212
* Healthy control participant\* meeting the following criteria:

  * No anemia or thrombocytopenia
  * No history of venous thromboembolism (deep vein thrombosis, pulmonary emboli)
  * No history of coronary artery disease or stroke
  * No chronic inflammatory disease
  * No diabetes mellitus
  * Have not smoked tobacco within the past 6 months NOTE: \* Selected on the basis of gender and age to match the patients as they are accrued

PATIENT CHARACTERISTICS:

* No symptomatic infections or other acute illness within the past 14 days

PRIOR CONCURRENT THERAPY:

* At least 3 days since prior drugs known to inhibit platelet function
* At least 7 days since prior acetylsalicylic acid
* No concurrent estrogen contraceptives or hormone replacement therapy
* No concurrent anticoagulants
A Study of Single and Repeated Doses of LY3556050 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Participants with a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²) and have body weight of 50 kg or more.

Exclusion Criteria:

* Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on Electrocardiogram (ECG).
* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy.
* Has asthma or other severe respiratory disease.
* Is pregnant, lactating, or planning a pregnancy.
* Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization.
* Any abnormal laboratory finding or vital signs outside specified parameters.