cyrilzakka/clinical-trials huggingface dataset:
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.

This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.

1. Evaluation of safety Primary outcome: all adverse events occurring in the subject
2. Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female between the ages of 20 and 80
* Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
* Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
* Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted

Exclusion Criteria:

* Pregnant or lactating women
* Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
* Patients with life expectancy less than 12 months
* Patients expected to receive a kidney transplant during the trial
* Patients with current or suspected infection
* Acute psychiatric problems require treatment
* Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
* Patients with coagulation disorder, platelet count \<50,000 / Ul
* Patients with a neutrophil count of less than 1,500 cells / mm3
* Patients judged to be unable to insert grafts by the operator
Description of Fluid Balance in Patients With Acute Respiratory Failure

The specific aim of this study is to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration.

Disruption of fluid balance is common in critical illness. Many critical illnesses are inflammatory in nature and associated with capillary leak and swelling of tissues. While fluid administration may be necessary for the immediate resuscitation of a patient in shock, in the long term it may worsen survival and lead to complications. This is especially true in acute respiratory failure, where excess fluid can lead to a longer duration of mechanical ventilation, longer time in the ICU, and a greater need for dialysis. There is also evidence that conservative fluid administration can prevent complications. Fluid overload is associated with increased healthcare resource utilization and cost.

Much of the fluid administered to patients while in the adult ICU in the United States is administered as medications via large volume infusion pumps. This is a descriptive study to gather data on fluid balance, intravenous medication administration, electrolyte balance, and diuretic and dialysis use in patients with acute respiratory failure who might benefit from a strategy designed to limit fluid administration. The information will be used to design an interventional trial of small volume medication infusion.

Eligibility Criteria:
Inclusion Criteria:

* Intubation and mechanical ventilation for ≤ 7 days
* An underlying condition associated with acute respiratory failure (e.g. pneumonia, ARDS, sepsis, asthma, COPD exacerbation)
* If in shock (MAP \< 60, fluid bolus ≥30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine ≤ 5 mcg/kg/min or low-dose (≤ 0.04 IU/min) vasopressin) there should be no fluid bolus (1000 mL crystalloid or equivalent) for at least 12 hours

Exclusion Criteria:

* Intubation or mechanical ventilation for \> 7 days
* Respiratory failure (requirement for positive pressure ventilation) in past 30 days
* Shock (MAP \< 60, fluid bolus ≥30 ml/Kg or 4 L crystalloid or equivalent, vasopressors except for dopamine ≤ 5 mcg/kg/min or low-dose vasopressin) requiring fluid bolus (1000 mL crystalloid or equivalent) within past 12 hours
* Presence of a condition making it unlikely that the patient will be liberated from mechanical ventilation within the next 28 days (e.g. quadriplegia, end-stage lung disease, massive stroke, etc.)
* Prognosis from underlying condition ≤ 28 days (estimated 28 day mortality from underlying condition \>50%)
* Likely intention (\>50% probability) to withhold or withdraw life-supportive care within next 28 days
Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development

This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.

Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.

Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old. Participants will attend a baseline study visit that will include eligibility assessment, urine collection, measurement of vital signs, dispensing of study medication, and an ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum. Vital signs will be taken, urine samples will be collected, and study medication will be given at each visit. Two blood samples will be taken between Weeks 32 and 36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old. Follow-up visits will be held every 6 months until the baby is 18 months old.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Between 10 and 18 weeks gestational age
* Healthy
* Diagnosis of psychosis

Exclusion Criteria:

* Use of any tobacco or nicotine product
* Drinks more than 1 alcoholic drink per day
* Use of illicit drugs
* History of trimethylaminuria
* History of kidney disease
* History of liver disease
* History of pre-pregnancy diabetes
* History of Parkinson's disease
* History of fetal death, fetal/infant congenital malformation, or fetal/infant genetic abnormality
* Evidence of noncompliance to study medication
99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.
Language Localization Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Epilepsy

Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.

Repetitive transcranial magnetic stimulation (rTMS) may be able to provide a moderately detailed localization of language functions in the brain. We propose to test the ability of rTMS to locate the substrate of visual naming to a limited area of the temporal lobe in patients with temporal lobe epilepsy before and after surgical resections. The study is expected to yield information on the organization of language in the temporal lobes and how unilateral temporal lobe lesions and lobectomy cause relocation of language mechanisms in the lesioned and in the other hemisphere. It will also be a preliminary step in the development of a clinically useful procedure for locating critical language areas in potential surgical candidates.

Eligibility Criteria:
Patients will be drawn from among those referred to the NINDS Epilepsy Research Branch.

No patients with evidence for a progressive neurological disorder.

No subjects with metal hardware in the cranial cavity, cardiac pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or evidence of increased intracranial pressure.

Women must not be pregnant.
Influencing Factors of Acute Achilles Tendinopathy in Runners

Achilles tendinopathy is highly prevalent in runners, but its evolution is not easily predictable. The aim of this study is to evaluate the impact of clinical and social factors on the prognosis of acute (less than 3 months) Achilles tendinopathy in runners. Runners will be evaluated in person twice. At their first visit, data related to their training (frequency, intensity, ...), their running pattern (cadence, foot contact angle) and shoes (minimalist index) will be collected. Moreover, an ultrasound evaluation of Achilles tendon will be performed. At one, two and three months after their initial evaluation, participants will receive a link to complete an online survey about their pain. Three months after their initial evaluation, a second ultrasound of Achilles tendon will be performed.

At their first visit, participants will read and sign the consent form. They will then fill self-report questionnaires about their pain (using the Victorian Institute of Sport Assessment for Achilles tendinopathy score and visual analog scale) and its impact on their activities, and they will be questioned on their training habits. Then, participants will be asked to run on a treadmill for five minutes at a comfortable speed. During the run, video will be recorded to evaluate to cadence and the foot contact angle. Finally, an ultrasound of Achilles tendon will be performed to evaluate thickness, area, echogenicity and inflammation of the tendon. All the images will be revised by a physician qualified in diagnostic ultrasound and the tendinopathy will be graded according to Matthew and al. model.

One, two and three months after their initial visit, participants will receive a questionnaire by email to quantify their pain. Moreover, three months after their initial visit, participants will come back in person to the laboratory. Information about their pain, training and treatment will be collected and a second ultrasound analysis will be performed.

Statistical analysis: Baseline data will be compared using independent t-test or a Mann-Whitney U test. Significant variables in the univariate analysis will be considered as potential predictor variables. Logistic analysis regression will then be performed to identify predictive factors for pain chronicity.

Eligibility Criteria:
Inclusion Criteria:

* Have Achilles tendon pain for less than three months
* Run at least five kilometers per week
* Have a score on the Victorian Institute of Sports Assessment of Achilles tendinopathy of 80 or less
* Consent to the study

Exclusion Criteria:

* History of Achilles tendon surgery or rupture
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors

The purpose of this study is to evaluate the safety, RP2D and PK/pharmacodynamic profile of ES101 monotherapy in patients with advanced NSCLC and to further evaluate the antitumor efficacy of ES101 in advanced malignant thoracic tumors, including NSCLC and SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent form.
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
* At least one measurable lesion is required (RECIST v1.1)
* Phase 1b: Subjects with pathologically or cytologically confirmed recurrent or metastatic NSCLC without known EGFR mutation and ALK and ROS1 gene rearrangements.
* Phase II: Subjects with pathologically or cytologically confirmed recurrent or metastatic malignant thoracic tumours who have received 1-2 lines of systemic anti-tumour therapy, including platinum regimens, and have failed, including at least 2 cycles of chemotherapy.

Exclusion Criteria:

* Prior exposure to 4-1BB agonists.
* Receipt of any anticancer investigational product or any approved drug(s) or biological products (except hormone-replacement therapy, testosterone or oral contraceptives) within 4 weeks prior to the first dose of study drug. Previous exposure to oral fluorouracils or small molecular targeted drugs require a minimum washout period of 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer). Previous exposure to mitomycin C or nitrosourea requires a minimum washout period of 6 weeks prior to the first dose of study drug.
* Receipt of PD-L1 therapy within 24 weeks prior to the first dose of study drug.
* Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES101.
* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
* Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before teh first dose of study drug. Certain exceptions as defined in protocol apply.
* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
* Systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug.
* Pregnant or nursing females.
RARC vs LRC in A Multicenter Cohort Study

A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old; Clinical stage Ta-T4a/N0-3/M0

Exclusion Criteria:

* Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.
Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial

To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.

Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted for open colonic surgery

Exclusion Criteria:

* no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19

A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed positive for COVID-19 by RT-PCR assay or equivalent
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
* Able to swallow capsules
* Willing to follow contraception guidelines

Exclusion Criteria:

* Pregnant or breast feeding
* Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19
* Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1
* Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
* Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)
* Any condition that confounds the ability to interpret data from the study
* Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study
Telehealth Enhanced Asthma Management

This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (TM) vs. in-person (IP) visits.

The overarching hypothesis is that utilization of TM for asthma follow-up will result in improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and medication adherence compared to participants receiving IP follow-up care. The Investigator also hypothesize that TM follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (TM) compared to those who travel a distance to receive care (IP).

Eligibility Criteria:
Inclusion Criteria:

1. age ≥6- and ≤18 years
2. persistent asthma as defined by national guidelines standards
3. receives care at an ACH asthma subspecialty clinic
4. reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR

Exclusion Criteria:

1. Significant underlying respiratory disease other than asthma, such as cystic fibrosis
2. significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video
3. current smoker
4. severe asthma exacerbation requiring intubation in the past 12 months
5. no access to a smartphone or internet
A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache

This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
* Eight (8) headache days per month for at least 1 of the preceding 15 months

Exclusion Criteria:

* Not currently diagnosed with chronic migraine, headache or migraine
* History of receiving botulinum toxin injections for the treatment of chronic migraine.
PharmacoMRI of Parkinson Disease

Based on studies showing better responsiveness of motor versus cognitive symptoms to Parkinson's Disease medication, also known as dopaminergic treatments, the investigators hypothesize that comparison of resting state networks in the on versus off medication state in Parkinson's Disease patients will show greater effects on brain networks associated with motor control.

Subject participation includes two 25-30 minute MRI scans. The subject will arrive in the "off" state (PD medications withheld for approximately 12 hours prior to the scan). Following the initial scan, the subject will receive 125% of his or her usual daily morning dose of PD medications which is calculated as levodopa dose equivalents (LDE) and is given as carbidopa-levodopa. The subject will then wait for an hour allowing for the medication to begin working. During this time the subject will complete cognitive assessments, questionnaires regarding the history and current state of PD, and motor assessments. The subject will then undergo a second MRI scan of approximately 25-30 minutes. The subject after completing the second MRI scan is free to leave. The entire study is approximately 2 and 1/2 hours long.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD)
* Older than 30 years of age at the time of diagnosis
* Hoehn and Yahr stage greater than or equal to 2.5
* PD duration greater than 3 years
* Stable regimen of PD medications for at least 2 weeks prior to imaging
* PD medications include carbidopa-levodopa

Exclusion Criteria:

* Patients with a diagnosis of other neurodegenerative conditions
* Patients unwilling or unable to give informed consent
* Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan