cyrilzakka/clinical-trials huggingface dataset:
Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency

The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis (\>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment. Patency will be assessed with a new fluorescence angiography technique as well as ultrasonic transit-time flow measurement. We hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We also hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We expect both groups will experience similar perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative patency assessment and graft revision will experience improved long-term graft patency and freedom from late clinical events at 5-6 years post-operatively.

The immediate and long term success of coronary surgery is dependent on the construction of a high quality anastomosis with a durable conduit to an appropriate target coronary vessel. Significant advances in medical therapy including early post-operative aspirin administration and increased use of arterial grafting have improved early, midterm and late graft patency. However, modern coronary bypass series continue to report perioperative graft occlusions rates as high as 11%. These very early graft failures have been predominantly ascribed to technical problems at graft anastomosis sites and may be preventable. New intraoperative graft assessment technologies have recently become available which can identify technical problems such that they can be repaired in the operating room. However, these techniques increase the length of the bypass operation and may have false positives, which may lead to unnecessary and potentially damaging graft revisions. The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis(\>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.

Eligibility Criteria:
Inclusion Criteria:

* isolated aortocoronary bypass surgery
* left ventricular ejection fraction \>20%
* expect at least 2 bypass grafts

Exclusion Criteria:

* renal insufficiency (creatinine \>180 umol/L)
* known allergy to indocyanine green contrast dye
* severe peripheral vascular disease precluding femoral access
* known allergy to radiographic contrast media
* women of childbearing potential
* co-morbid illness which precludes the use of follow-up angiography
* geographically inaccessible for follow-up angiography
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
* Patients giving informed consent to participate in the survey

Exclusion Criteria:

* Non-ambulatory patients
* Illiterate patients and patients otherwise unable to complete a written survey
The Anemia Control Program: Early Intervention

The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.

Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.

Eligibility Criteria:
Inclusion Criteria:

* birth weight \>= 3.0kg
* singleton full-term birth
* routine vaginal delivery
* no major congenital anomalies
* no major perinatal complications
* no photo therapy
* no hospitalization for longer than 5 days
* no chronic illness
* no iron therapy
* from 1991-94, infants on \>= 250 ml/day cow milk or formula
* from 1994-96, infants could be on \< 250 ml/day cow milk or formula
* infants identified as anemic at 6 or 12 months and randomly selected nonanemic infants at 6 and 12 months

Exclusion Criteria:

* residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile
* another infant \<12 months in household
* infant in child care
* illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments.
* until mid-1994, "exclusive" breastfeeding, defined as \>250 mL/d cow milk or formula
Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

The purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. Participants will be randomized to one of four arms: treatment-as-usual (TAU), cannabidiol 17mg/mL, cannabidiol 37mg/mL, or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Presenting for an operatory appointment at University of Tennessee Health Science Center College of Dentistry Oral and Maxillofacial Surgery Department
* Operation must be a simple tooth extraction which does not result in an opioid prescription
* 18 years of age or older
* Have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages

Exclusion Criteria:

* Contraindication to ibuprofen
* Contraindication to acetaminophen
* Contraindication to cannabidiol or hemp oil
* Contraindication to peppermint oil
* Contraindication to almond or other tree nuts
* Currently taking a form of cannabidiol and unwilling to stop use for one week post surgery
Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa

Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in western society. In this pilot study, the investigators aim to evaluate an acupuncture treatment tailored to the RP population for its feasibility to improve visual function, specifically visual field and dark adaptation. The study results may provide a basis for eye care providers' recommendations to RP patients regarding whether to consider acupuncture as a potential treatment modality. If our hypotheses regarding improvements in vision beyond typical test variability are supported, our future research goals include the conduct of a larger clinical trial with involving randomization and a placebo control for acupuncture in RP.


Eligibility Criteria:
Inclusion Criteria:

* Age 10+
* Diagnosis of retinitis pigmentosa
* Best-corrected visual acuity better than 20/400 in at least one eye
* More than 20% loss of Goldmann Visual Field area (III4e) in at least one eye
* Able and willing to participate in all study visits in Baltimore for the 8-week program
* Provide informed consent

Exclusion Criteria:

* Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
* Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
* Schedules do not permit participation in all study visits
* Previous acupuncture treatment in the last 6 months
* Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
* Dementia; Long or short-term memory loss
* Unable to read or speak English
* Smoking, substance abuse, or illegal drug use
* Receiving current psychiatric care (i.e. unstable emotional and mental health status)
* History of excessive bleeding
Convalescent Plasma to Limit Coronavirus Associated Complications

Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
* Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

* Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers

Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.


Eligibility Criteria:
Major Inclusion Criteria:

1. Able to provide written informed consent
2. Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception or who are sterile
4. Stable cardiac status
5. Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Major Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)
2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
3. History of hemiplegic or basilar migraine
4. Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial
Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma

Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.

Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.

This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.

Eligibility Criteria:
Inclusion Criteria:

* Received treatment for asthma in the year prior to study entry
* Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry
* Continuous Kaiser Permanente membership from the year prior to study entry through study entry
* Willing to participate in the study

Exclusion Criteria:

* Excluded from primary analyses if fewer than three months of follow-up
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.


Eligibility Criteria:
Inclusion Criteria:

* Female with a diagnosed breast focal lesion

Exclusion Criteria:

* Allergic conditions to contrast media,
* asthma,
* R-L shunt
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.


Eligibility Criteria:
Inclusion Criteria:

* No fever on day of vaccination
* Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
* Underlying chronic illnesses must be stable

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Have recently received blood products other than autologous blood transfusion
* Pregnant or breast feeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Use of nontopical antiviral therapy with activity against herpesvirus
Human Epididymis Protein 4 in Women With Severe Preeclampsia / HELLP Syndrome

Pre-eclampsia seems to be associated with a four to five times increase risk of later microalbuminuria and CKD which might suggest a possible direct renal damage from pre-eclampsia


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women 18-35 years old.
2. Fulfilling the criteria for diagnosis of sever preeclampsia.
3. Fulfilling the criteria for diagnosis of HELLP syndrome

Exclusion Criteria:

1. Diabetes mellitus
2. Preexisting renal disease.
3. Chronic hypertension
4. Rheumatologic diseases
5. Adnexal mass.
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy

This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.

Participants will be assessed 2 times - before and after training with the robot. All the testing and training sessions will be carried out at Spaulding Rehabilitation Hospital and will include:

Clinical tests:

* A test to evaluate gross motor function
* A test to assess walking speed
* A test to assess endurance

Muscle activity tests:

* A test to derive detailed measures of how well participant walk using a camera-based motion capture system.
* Special sensors (called electromyographic - EMG - sensors) will be used to determine when and how muscles are recruited to generate movements.

Training with the Robot:

Study participants will undergo 18 sessions of robot-assisted gait training for 18 time The training sessions will be carried out by trained study staff. The robot will assist study participants to walk. Each training session will last about 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spastic cerebral palsy
* 6 to 18 years of age
* Gross Motor Function (GMFCS) Level I, II, III or IV
* Femoral length \< size of robotic exoskeleton used for gait training (femur length between 210-350mm)
* Ability to communicate pain or discomfort

Exclusion Criteria:

* Recent use of Lokomat within the last 3 months
* Contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis)
* Skin ulcers in trunk or lower limbs
* Hip, knee, ankle arthrodesis
Cost Effectiveness in Alveolar Bone Grafting in Patients with Cleft Lip and Palate

The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.


Eligibility Criteria:
Inclusion Criteria:

* Patient with CLP(unilateral or bilateral)
* Radiographically evident open bone defect of the alveolus
* Dentition evaluated by orthodontist and cleared for ABG surgery

Exclusion Criteria:

* Patients without CLP
* Previous failed repair of alveolar cleft
* Patients who have previously undergone successful ABG
* Patients without an alveolar defect
* Patients whose parents refuse to consent to randomization
* Patients who have a syndromic CLP
Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.

The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
2. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
3. Age 18-70.
4. At least one of the tumor lesions measurable.
5. Functional Status: PS (ECOG) \> 0-1.
6. Normal Bone Marrow Function: White blood cell count \> 4×109/L, hemoglobin \>90g/L, and platelet count \>100×109/L.
7. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) \< 1.5 x ULN and serum creatinine \< 1.5 x ULN.
8. Life expectancy of more than 6 months.
9. All the patients signed the informed consent.
10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Patients with recurrent cervical lymph nodes alone.
2. Evidence of distant metastasis
3. The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
4. Creatinine clearance \< 30ml/min
5. Has received epidermal growth factor targeting therapy.
6. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
7. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
8. Active systemic infection.
9. History of Serious lung or heart disease.
10. Drug or alcohol addiction.
11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
12. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
13. To receive chronic systemic immunotherapy or hormone therapy other than this study.
14. Women who are pregnant or breast feeding
15. Participation in other drugs clinical trials within 1 month.
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia

In this scheme, TMS treatment of Primary dystonia is planned by precise magnetic resonance positioning.


Eligibility Criteria:
Inclusion Criteria:

* Primary dystonia

Exclusion Criteria:

* None
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.


Eligibility Criteria:
Inclusion Criteria:

* Subject was treated in Study 20090
* Age less than 13 months of chronological age
* Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

- Subject has a condition preventing participation in the study, or performance of study procedures.