cyrilzakka/clinical-trials huggingface dataset:
Argus II/ORCAM Device Study

This study is being done to determine if wearable text-to-speech (TTS) and visual pattern recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow patients to read and recognize faces and objects.

The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare light-perception vision. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. Current limits in the resolution of the device prevent useful reading or face recognition. The FDA has approved the Argus II as a humanitarian device.

Present-day wearable text-to-speech converters are also capable of object and face recognition. Such systems have been developed to assist with these tasks in patients with severe low-vision. ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.

The Orcam device will be mounted onto the Argus II eyeglasses. The subject will be asked to use the Orcam device with and without the Argus II. After a half-day interactive training session with the Orcam device, the investigators will interview the subject with a questionnaire. The investigators will then contact the subject every two weeks via a telephone call for two months (4 phone interviews). The investigators will then ask the subject to return to Mayo Clinic to demonstrate their ability to use the Argus II and Orcam together and separately. These sessions will be videotaped.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced retinitis pigmentosa
* Subjects must have an Argus II device implanted to be eligible for this study
* Subjects must be familiar with using their Argus II device

Exclusion Criteria:

- No Argus II implant
Care Transition Intervention for Patients With Cancer

This research study is investigating an intervention called CONTINUity of care Under Management by Video visits (CONTINUUM-V). CONTINUUM-V involves a video visit with an oncology nurse practitioner within three business days of hospital discharge for patients with advanced cancer with the goal of reducing burdensome care transitions after hospitalization, including hospital readmissions.

This is a single-site, single-arm pilot trial to assess the feasibility and acceptability of a CONTINUUM-V for patients with advanced cancer

The research study procedures include:

* A video visit with a nurse practitioner within three business days of hospital discharge
* Questionnaires asking about demographic information (e.g. sex, ethnicity, income) and participant experience with cancer (e.g. symptoms and confidence in managing their health condition)
* A satisfaction survey to assess the participants' impressions of the intervention and any suggestions the participants may have
* Data collection from their medical record
* One time interview of participant and clinician for feedback on CONTINUUM-V

Participants will be in this research study for up to 45 days after hospital discharge.

54 patients and 4 clinicians took part in this research study.

The Conquer Cancer Foundation and the Rising Tide Foundation for Clinical Cancer Research are supporting this research study by providing a Career Pathway Grant in Symptom Management to support the research team.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. Unplanned admission to the oncology service at Massachusetts General Hospital (MGH)
3. Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancers. Advanced cancer defined as not being treated with curative intent as determined by clinic notes and chemotherapy order entry.
4. Receiving ongoing oncology care at MGH
5. Verbal fluency in English
6. Must have internet/wifi/cellular data access

Exclusion Criteria:

1. Admitted electively
2. Discharged to a location other than home or expired during admission
3. Discharged with hospice services
Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.

This study will establish a comparison in follow-up care of 100 patients between Health Care Practitioners, more specifically the rheumatologist and a trained nurse. The study objective is to show consistency of evaluation between two different health care professionals, a physician and a nurse.

This study involves one site in Canada. Patients will complete a self-evaluation of 28 joint counts for swelling (SJC) and tenderness (TJC) and assess their disease activity on a Visual Analog Scale (VAS). A 28 joint count and VAS will then be assessed by a nurse and by a rheumatologist. Clinical Disease Activity Index (CDAI) and Disease Activity Severity 28 - C Reactive protein (DAS28-CRP) will be calculated from each data set.

The same rheumatologist will examine all patients and two nurses will each randomly assess half the total enrolled patients. The nurse will be blinded to the patient's joint count and VAS, and similarly, the rheumatologist will be blinded to both the patient and nurse's assessments. The setting includes 2 nurses with different educational background: one technician and one bachelor.

The training provided to the nurses in this study allows them to master the basis of the physical exam, joint count and history of the rheumatoid patient as well as to learn the pertinent laboratory parameters. It is a 14-hour course in which the patient is examined through observation, palpation, assessment of mobility and stability and specific movement. Diagnostic tools such as the Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire Disability Index (HAQ), CDAI and DAS-28 are included in the patient evaluation.

Each enrolled patient will receive a 5-minute training in joint assessment by the nurse. The use of the mannequin for joint assessment of swelling and tenderness will be reviewed. Objective signs of disease such as swelling, redness and heat will be explained as well as the difference between inflammation and bony swelling, the latter being indicative of osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age.
2. Has at least one of the following diagnosis at screening

   * Subject has a diagnosis of RA as defined by the 1987- revised American College of Rheumatology (ACR)- classification criteria for RA and has disease duration of more than 6 months.
   * Subject must have a diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) and has disease duration of more than 6 months.
3. The subject must be able to provide written informed consent and to complete the study questionnaires.

Exclusion Criteria:

* Subject with DIP involvement in PsA
* Subject with predominant axial symptoms (spondyloarthropathy)
* Subject with fibromyalgia
* Subject involved in a concomitant study
* Subject currently takes ≥10 mg cortisone daily
* Subject has taken opioid analgesics within 12 hours of joint count assessment
Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)

Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion. However, there have been very few randomized clinical trials to support use of any of these treatments. Several animal studies and observational reports suggest that ARBs can be useful in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated, multi-center, randomized controlled open-label trial. Patients with small AAA (aorta diameter \<5cm) will be randomized 1:1 either to valsartan or to atenolol group. Randomization will be stratified by the AAA size (max. diameter \>4 cm or ≤4 cm). Patients will receive either valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or more) for 12 months. A CT scan will measure the maximal diameter of AAA at baseline and 12 months. The annual growth of AAA will be compared between the valsartan and the atenolol group.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20years
* Abdominal aortic aneurysm with maximal diameter less than 5cm
* Hypertension
* Patient with signed informed consent

Exclusion Criteria:

* Saccular type aneurysm, inflammatory aneurysm, or infected aneurysm
* Aortic dissection
* Planned surgery or endovascular therapy for abdominal aortic aneurysm within 1 year
* Previous aorta surgery or endovascular therapy
* Contraindications to Beta-blocker or ARB (allergic reactions, asthma, severe bradycardia, angioedema, hyperkalemia)
* Allergic reaction to contrast dye
* Known genetic aorta disease or autoimmune or connective tissue disease: Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease
* Pregnancy
* Life expectation \<1 year
* Renal failure (serum Cr \>2.0 mg/dL)
* Liver disease (ALT or AST \> 3 x upper limit) or liver cirrhosis (Child B or C)
* Malignancy requiring surgery or chemotherapy within 1 year after enrollment
* Status post transplantation or chronic inflammatory disease requiring immune suppressive drugs over 4 weeks
Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures

This randomized controlled trial evaluates the effectiveness of augmented reality (AR) as a distraction technique to reduce procedural pain and anxiety in children aged 6-10 undergoing primary tooth extraction. Participants will be randomly assigned to receive either AR distraction via VR goggles or standard tell-show-do behavior management during local anesthesia administration and extraction.

Pain and anxiety are major challenges in pediatric dental care. AR presents an innovative, non-pharmacological technique to manage procedural distress. The study compares AR distraction versus conventional behavioral guidance in terms of self-reported pain (Wong-Baker FACES), dental anxiety (CFSS-DS), and physiological anxiety (heart rate monitoring). A double-blind design will ensure unbiased outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-10 years

Indicated for anterior primary tooth extraction

No previous exposure to local anesthesia

Exclusion Criteria:

* Medically compromised children

Children with cognitive or communication impairments

Children who underwent similar treatment within the past 3 months
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR

A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements

The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.

Eligibility Criteria:
General Inclusion Criteria:

1. Patient must be at least 18 years old and less than or equal to 75 years of age
2. Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
3. Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment

Angiographic Inclusion Criteria:

Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography

General Exclusion Criteria:

1. Patients unable to provide informed consent
2. Patients in pregnant state
3. Known renal insufficiency or failure (serum creatinine level of \> 2.5 mg/dL, or on dialysis)
4. Allergy to the contrast
5. Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
6. Spastic bronchial asthma
7. ST elevation coronary syndrome
8. Hemodynamic instability
9. Contraindication to nitroglycerin or ATP
10. Current participation in another investigational drug or device clinical study that may affect the FFR measurements

Angiographic Exclusion Criteria:

CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

The study population will be randomized to two groups: ZEPLAST and control, respectively.

The two groups will receive the same priming solution (containing Red Blood Cells and albumin 5%) and heparin/protamine management. In both groups coagulation will be assessed with rotational thromboelastometry (ROTEM - EXTEM, INTEM, HEPTEM and FIBTEM tests) after heparin antagonization. In case of bleeding, coagulopathies will be treated differently:

* in the ZEPLAST group, fibrinogen deficiency (FIBTEM Maximum Clot Firmness MCF \< 8 mm) will be treated with 30 mg/kg of concentrated fibrinogen; low thrombin generation (EXTEM Clotting Time CT \> 100 s) will be treated with 20 mg/kg of prothrombin complex concentrate;
* in the control group, coagulopathies will be treated with 10-20 ml/kg of FFP. In case of refractory bleeding, PCC and fibrinogen can be administered as a rescue treatment.

Further ROTEM tests will be performed at 24 and 48 hours post surgery. Outcome parameters will be collected at the same timepoints.

Eligibility Criteria:
Inclusion Criteria:

* newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation:
* informed consent signed by both parents or legal guardian.

Exclusion Criteria:

* emergency surgery;
* known congenital coagulopathy or suspected based on anamnesis;
* participation to other clinical trials;
* known hypersensitivity to components and excipients of FFP , prothrombin complex concentrate or fibrinogen concentrate.
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age
* Weight of at least 12 kg and capable of swallowing a capsule
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Stable fiber therapy or ADHD therapy if using such medications
* Patient/Caregiver able to complete daily diary
* Patient able to use recommended rectal and/or oral rescue medications if needed

Exclusion Criteria:

* Constipation is associated with some medical, anatomic, physical, organic, or other condition
* Hirschsprung's Disease or Nonretentive Fecal Incontinence
* Untreated fecal impactions or impactions requiring digital manipulation
* Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
* Sexually active males and females must utilize acceptable birth control methods
* Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in plasma of SLE patients and difference in their expression among groups with different systemic lupus erythematosis disease activity index (SLEDAI) scores.


Eligibility Criteria:
Inclusion Criteria:

* Adult systemic lupus erythematosis patients

Exclusion Criteria:

* Patients younger than 18 years, patients with other autoimmune diseases or malignancy.
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test

The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)


Eligibility Criteria:
Inclusion Criteria:

* healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy

Exclusion Criteria:

* pre-existing diabetes, or failed to perform the OGTT
Short Term Effects of Photodynamic Therapy in Basal Cell Carcinoma

The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of Basal cell carcinoma (BCC) and factors that affect response rate.

Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.

Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven BCCs

Exclusion Criteria:

* Rodent ulcer
* Morphea type
* ANA +
* History of photosensitivity or photodermatosis or ingestion of phototoxic
* Drugs during last month
* Pregnancy
* Breast feeding
* Age\< 18
* History of another therapeutic intervention for bcc during last 6 months
Smog Induced Indoor Air Pollution in Homes of Chronic Obstructive Pulmonary Disease Patients.

Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog). The first goal will be to measure baseline parameters for 50 homes, including information about the building, ventilation characteristics, pollution levels (indoors and outdoors), and occupant survey information. In a subset of these homes, either passive or active control systems will be installed and the impact of these systems on indoor concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a given point in time) over a 16-month period. Participants will be followed for approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1 week (baseline verification) and after four weeks with the control system in the home (at the end of study week 5).

Chronic obstructive pulmonary disease (COPD) is a degenerative lung disease resulting in lower lung function characterized by an obstruction to airflow. COPD is an umbrella term for two disease processes: chronic bronchitis and emphysema. It is currently the 4th leading cause of death in the United States. Approximately 14 million Americans are known to suffer from COPD; however, it is estimated that as many as 24 million Americans may have some form of one or both of the diseases (Centers for Disease Control, 2011). The primary risk factor for developing COPD is cigarette smoking; other factors include exposure to air pollution, occupational dusts and chemicals, and lower socioeconomic status. Poverty has been identified as a risk factor for COPD but the aspects related to poverty that increase the risk of COPD are unclear (GOLD, 2011). Lower education level and household income has been noted to relate to increased severity of COPD (Eisner, Blanc, Omachi, Yelin, Sidney, Katz, et al, 2011). An American Lung Association survey found that over half of those diagnosed with COPD reported that their condition limits their ability to perform activities of daily living, including activities in the home (American Lung Association, 2009). As air pollution can lead to an exacerbation of COPD symptoms and precipitate emergency room visits and hospitalization, minimizing pollution in indoor air may be a key component of disease management and decreasing health care costs.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD (stage III or IV); adults over the age of 18 years

Exclusion Criteria:

* Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease

The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic hepatitis by biopsy
* Patients over 20, under 65 years of age.
* Patients with abnormal transaminase value.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
* Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
* Toxic hepatitis, alcoholic hepatitis.
* Total bilirubin value more than 3.0 mg/dl.
* Albumin value less than 3.0 g/dl.
* Patients who participating in other study about drug.
Nutritional Support for Cardiac Rehabilitation

In this randomized trial the primary outcome is to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 6 (IL-6).

Hypothesis: Secondary outcomes are to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 1β (IL-1 β), tumor necrosis factor and C Reactive Protein (CRP); may increase anti-inflammatory interleukin 10 (IL-10) plasma concentrations and may change Gut Microbiota (GM) composition.


Eligibility Criteria:
Inclusion Criteria:

* Admission for cardiac rehabilitation
* Signed informed consent

Exclusion Criteria:

* Patient unable to eat orally
* Eating disorders
* Indication to Levodopa therapy
* Gastrointestinal malignant diseases
* Known kidney failure
* Known liver failure
* Previous antibiotic therapy
* Refusal