cyrilzakka/clinical-trials huggingface dataset:
PET Imaging CCR2 in Lung Inflammation

The primary objective of this study is to assess the lung distribution of the Positron Emission Tomography (PET) imaging radiotracer Cu-DOTA-ECL1i, which binds to the specific population inflammatory cells, in patients with fibrotic lung diseases. This objective includes sub-studies to assess radiotracer distribution in the lung, the reproducibility of PET scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue. The overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases.

This is a single site, pilot Phase 0/1 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease (n=60). Healthy volunteers without known pulmonary disease will be recruited as controls (N=5). All subjects will be recruited and undergo one dynamic PET/CT scan to characterize the lung uptake of Cu-DOTA-ECL1i. Among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second PET/CT within two months. A third subgroup of subjects (n=10) who undergo lung transplant will have analysis of CCR2+ cells in their explanted lungs.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 21 years of age or older who have never smoked or current smokers who smoked at least 10 cigarettes per day (1/2 pack) and have smoked at least 100 cigarettes (5 packs) over the past month.
* Screening FEV1 and FVC \> 80% of predicted
* Capable of lying still and supine within the PET/CT and PET/MR scanner for \~1 hour and follow instructions for breathing protocol during the CT portion
* No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
* No known history of cardiac, pulmonary, hepatic or renal disease or diabetes
* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
* Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol
* BMI ≤ 35

Exclusion Criteria:

* Currently enrolled in another study using an investigational drug
* Pregnancy (confirmed by urine pregnancy test)
* Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
* Currently taking any prescription medications
* Presence of an implanted device that is incompatible with CT or MRI scanning
* Creatinine \> 1.30 mg/dL, AST \> 50 Units/L, ALT \> 55 Units/L, or total bilirubin \> 1.2 mg/dL
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion Criteria:

* Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
* Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
* Participants with an active, known, or suspected autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply.
Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials


Eligibility Criteria:
Inclusion Criteria:

1. On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the following conditions:
3. TG≤5.6mmol/L；

Exclusion Criteria:

1. (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
2. (2) Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200IU/ml, HBV-DNA ≥ the lower limit of the detection value);
3. (3) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
4. (4) Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
5. (5) Glomerular filtration rate (eGFR)\<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L);
A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to any study-related assessments
* Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
* Willing and able to follow instructions and can be present for required study visits

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
* Use of contact lenses within 90 days prior to Visit 1 and throughout the study
* Have had an ocular infection in either eye within 90 days prior to Visit 1
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:

* Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.
* Safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.

This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 28-days screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy of more than 3 months
* At least one measurable lesion according to RECIST 1.1
* Adequate organic function
* Signed and dated informed consent

Exclusion Criteria:

* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
* Major surgery within 30 days prior to the initiation of study treatment
* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
* Patients who are suffering active interstitial lung disease
* Evidence of ongoing or active serious infection
* History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
* Inability to take medication orally
* Abuse of alcohol or drugs
* People with cognitive and psychological abnormality or with low compliance
* Pregnant or lactating women
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
* Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion Criteria:

* Patient who have life expectancy under 3 months
* Patient who have severe metastasis of Liver or whole body
* Patient who previously had surgical biliary drainage
Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation

Prospective, multicenter, spontaneous, non-interventional, non pharmacological. Study aimed at evaluate kinetics, diagnostic and prognostic value of pro-ADM (proadrenomedullin) as compared to PCT (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation (HSCT)

Evaluation of diagnostic performance of pro-ADM as compared to palliative care therapy (PCT) in paediatric and young adult patients with any type of complications after hematopoietic stem cell transplantation or with transplant related complications.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the parents/legal guardians and patient's assent/consent according to national regulations. For subjects who turn 18 years of age during participation in this study, participation in the future use portion of the study after their 18th birthday requires that they sign the informed consent statement following turning 18 years of age.
* Age at time of registration from 28 days to less than 39 years of age.
* Malignant disease (i.e. Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Myelodysplastic syndromes (MDS)) or nonmalignant disease (e.g. immunodeficiency or inherited disorders of metabolism or hemoglobinopathies etc.) indicated for allogeneic HSCT.

Exclusion Criteria:

* Age less than 28 days
* Obese patients with body mass index: \> 30 kg/m\^2.
* Impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (LVEF) ≤ 35%.
* Impaired liver function indicated by Bilirubin \>3 times the upper limit of normal (ULN), or aspartate aminotransferase/alanine aminotransferase (AST/ALT) \>10 times ULN
* Impaired renal function indicated by estimated glomerular filtration rate (GFR), according to the Schwartz formula for ages 1-17 and according to CDKEPI creatinine equation for ages above 17 years old) \< 60 mL/min/1,73m\^2.
* Concurrent severe active infection at the start of conditioning regimen
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination.
* For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient (e) old (e) over 18 years
* Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
* Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
* Indication of head and neck radiotherapy bilateral
* All of the TNM stage except metastatic
* Patient has signed informed consent for participation in the study
* Mastery of the French language

Exclusion Criteria:

* History of head and neck radiotherapy
* Indication of head and neck radiotherapy unilateral
* Personal history of malignant tumors uncontrolled over the past 5 years
* History of oral sicca syndrome
* Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
* Concomitant treatment with amifostine
* Concomitant treatment with cetuximab
* Primary tumor of the salivary glands
* Head and neck hyperfractionated radiotherapy and / or accelerated
* Head and neck radiotherapy hypofractionated
* Metastatic disease
* Patient deprived of liberty, under guardianship
* Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
* Refusal of the patient.
Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement

Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients.

This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female pregnant patients
* ≥19 years old
* Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia

Exclusion Criteria:

* Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits)
* Obesity (BMI \> 38 kg/m2)
* Use of arterial line for BP measurement
* Inability to read and understand English
MCO Membrane Efficiency in Septic Shock Patients

This is a monocentre randomized pilot study. All patients received two consecutive RRT: CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.

This is a monocentre randomized pilot study. All patients received CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.

The efficiency of the filters for small and middle molecules was compared in septic shock patients with AKI stage 3.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* septic shock according to ACCP/SCCM criteria
* AKI KDIGO stage 3
* clinical decision to begin citrate based-RRT for at least 48 hours
* Hb \>= 9 g/dL
* Obtain the informed consent

Exclusion Criteria:

* Pre-existing chronic renal insufficiency
* Weight \> 125 kg Life expectancy \<24 hr
* Declared do Not Resuscitate or Comfort Measures
* Platelets \< 20 \[10\^3/ul\] or active bleeding
* Pregnancy
* Contraindication to citrate
Investigation of the Effects of Inspiratory Muscle Training on Patients With Mechanical Low Back Pain.

There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity, disability, quality of life and sleep quality in people with mechanical low back pain.

When initial assessment will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).

All participants will receive the core stabilization exercise program designed for mechanical low back pain for 8 weeks. Additionally, the study group will receive inspiratory muscle training for 8 weeks.

All studies will be evaluated both at the beginning and end of the study in terms of pain, quality of life, sleep quality, disability level, muscle endurance and functional capacity. All data will be collected by the same physiotherapist at baseline and at the end of the study (8 weeks). The same physiotherapist will also supervise the exercises and inspiratory training.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-65
* Applying to the physical therapy unit with the diagnosis of mechanical low back pain (Lumbal disc herniation, spinal stenosis, spondylolisthesis, facet joint pain, discogenic pain, sacroiliac joint pain, myofascial pain, lumbar osteoarthrosis)
* Ability to adapt to exercise commands and understand assessment questions
* Volunteering to participate in research

Exclusion Criteria:

* Those with cooperation and communication problems
* Complaining of acute or chronic musculoskeletal pain other than low back pain
* Having a chronic disease (hypertension, diabetes, chronic obstructive pulmonary disease (COPD), previous cerebrovascular accident (CVO), heart, neurological and rheumatological problems)
* Sequestrated and extruded hernia
* Receiving physical therapy in the last 2 months
* Having a history of recent surgery (spine, abdomen, upper and lower extremity surgeries)
* Being obese (Body mass index ≥30 kg/m2)
* Contagious and vascular diseases
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine

The primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of chronic migraine compared to a placebo medication. A second objective, is to find out whether there is an improvement in quality of sleep and self-reported depression in patients taking Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients treated with Amrix 15mg daily will be significantly lower than those patients treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. males and females, aged 18 to 65, with headaches longer than 30 minutes per day for at least 15 days per month (28 days) meeting ICHD-IIR criteria for chronic migraine. Subjects must have headaches at least 8 days per month which are alleviated with triptans or ergots AND/OR which have at least 1 migrainous feature (unilaterality of headache or pain more prominent on 1 side of the head, throbbing, nausea, vomiting, photophobia, phonophobia, increased pain with physical exertion or avoidance of exertion)
2. subjects willing and able to perform all study-related measures including accurately completing study diaries and instruments, maintaining stable doses of headache preventative medications, completing study visits and obtaining blood testing as indicated.
3. women of childbearing potential must use an acceptable method of birth control for the duration of the study (oral contraceptives, IUD, injectable or intravaginal contraception or barrier methods combined with spermicide)

Exclusion Criteria:

1. subjects \<18 and \>65 years of age
2. pregnancy or attempted pregnancy during the study
3. nursing females
4. psychiatric condition which, in the investigator's opinion will influence trial safety or data collection
5. new daily persistent headache, hemicrania continua, chronic tension-type headache or cluster headache diagnoses.
6. headache suspicious for and not investigated to rule out secondary headache disorder
7. angle closure glaucoma
8. urinary retention
9. hepatic impairment felt by the investigator to interfere with study safety (as determined from history and/or prerequisite liver function testing within 1 year of study enrollment)
10. within 14 days of MAO inhibitor use or discontinuation
11. known hypersensitivity to cyclobenzaprine hydrochloride or any component of Amrix formulation
12. concomitant tramadol or tricyclic antidepressant use
13. history of myocardial infarction or congestive heart failure
14. hyperthyroidism
15. new start of daily preventative medication (which may influence headaches) less than 2 months preceding enrollment
16. dosage change or discontinuation of daily preventative medication (which may influence headaches) within 1 month of trial enrollment -
Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

When axial spondyloarthritis (SpA) occurs in Crohn's disease (CD) is an important clinical and research question that has not been fully answered. Magnetic resonance enterography (MRE), routinely obtained in Crohn's disease (CD) patients, can be utilized to assess sacroiliac joints (SIJ); currently published literature shows that it could be a valuable tool to detect active inflammation of sacroiliitis in CD patients. Only a small fraction of CD patients with MRE evidence of sacroiliitis is referred to rheumatologists for further evaluation. The proposed project aims to further define MRE features of sacroiliitis in CD by recalling subjects who had prior positive findings and assess the natural history and outcome of these cases by standard magnetic resonance imaging (MRI) of sacroiliac joints and SIJ X-ray. 37 CD subjects who were already found to have sacroiliitis in the previous MRE study will be recalled. Subjects will undergo standard MRI of SIJ, plain X-ray of SIJ and the rheumatologist will obtain detailed history and examine patients for evaluation of possible axial SpA. Other details pertaining to CD, CD therapy and activity, will also be obtained to help clarify a correlation between CD and axial SpA. This pilot study will allow better characterization of imaging features of sacroiliitis on MRE, provide useful information on clinical significance of these lesions in CD patients, and potentially establish MRE as a screening tool for early detection of sacroiliitis in CD patients.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of sacroiliitis on earlier standard of care MRE between 2014 and 2018.
* Confirmed diagnosis of Crohn's Disease
* Known HLA-B27 status at time of enrollment and most recent clinical ESR and CRP results from chart (from day of visit or within past 4 weeks of study visit)
* Adults \>18 years of age

Exclusion Criteria:

* History of other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout).
* Contraindication to MRI.
* History of malignancy \<5 years in remission, (except for non-melanomatous skin cancer).
* Inability to comply with study protocol.
* Critically ill patients.
* Pregnant patients.
* Non-English speaking patients (as the questionnaires used in this study are not validated in other languages)