cyrilzakka/clinical-trials huggingface dataset:
The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter

The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects.

The Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.

In this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.

Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.

The Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.

This is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old
* scheduled for routine bilateral eye dilation

Exclusion Criteria:

* narrow angles
* allergies to phenylephrine or tropicamide
* concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)
* baseline anisocoria (\>1 mm)
* traumatic pupil,
* surgical pupil
* unilateral pseudoexfoliation.
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.


Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for alcohol dependence or problem drinking.
* Age 18 years and older
* Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
* No participation in pharmacotherapy trial in the previous 30 days
* Not pregnant

Exclusion Criteria:

* Unable to provide informed consent
* Verbally or physically threatening to research staff
* Unable to communicate in Spanish
* Pending trials for a felony
* Childs-Pugh Class C Cirrhosis
* Grade 3 Hepatitis (LFTs \> 5X normal)
* Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
2. Age ranging from 19 to 80, both male and female
3. Obese patients，BMI ≥ 28kg/m\^2
4. ASA I\~III
5. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria:

1. Patients with acute respiratory infection in the last 2 weeks
2. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
3. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
4. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
5. coagulation disorders or platelets \< 100\*10\^9/L
6. Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets
7. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
8. Participated in other clinical trials as a subject within 3 months
9. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
10. Emergency procedure
11. Pregnant or breast-feeding women
12. Patients having procedures with planned tracheal intubation or laryngeal mask
13. Investigator considers the patients are inappropriate to participate in this trial
Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

* All races are eligible
* Malignant diseases: Leukemias and Lymphomas
* Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

Exclusion Criteria:

* Lansky or Karnofsky \> 70
* Echo \> 27% shortening fraction
* renal function:serum creatinine \< 1.5 x for normal age
* no active untreated infection
* DLCO \> 50% of predicted value
* Hepatic: AST and ALT \< 3x upper limit of normal; bilirubin \< 2.0.
Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study.

The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

- Patients with widespread malignant intra-abdominal ovary cancer stadium III-IV and are operated by extensive resection of intra-abdominal viscera as well as the parietal peritoneum (cytoreductive surgery, CRS)

Exclusion Criteria:

* Body mass index \> 35
* American Society of Anesthesiologists classification \> 3
* Renal dysfunction
* Allergic to acetylsalicylic acid
* Unwilling to provide informed consent
Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes, and Beliefs in Participants With Stage I-IV Gynecological Cancers

This trial evaluates the impact of a systemic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV gynecological cancers. Social work counseling and education may help increase the number of participants who complete medical power of attorney documents. Counseling and education may also affect attitudes about decision-making and willingness to take part in these conversations in participants with stage I-IV gynecological cancers and their family members and/or caregivers.

PRIMARY OBJECTIVES:

I. To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic social work counseling and education clinical process.

SECONDARY OBJECTIVES:

I. To determine change in medical power of attorney (MPOA)/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM).

II. To determine change in MPOA/primary family caregivers' knowledge of patients' values and goals for MDM.

III. Evaluate patients' and MPOA/primary family caregivers' willingness to participate in future advance care planning discussions to discuss patients' values and goals important to MDM.

IV. Evaluate predictors of patient subgroups most likely to respond to the social work counseling and education clinical process.

V. Explore aspects of the Spanish language version of the advance care planning engagement survey to inform future validation studies.

OUTLINE:

Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.

After completion of intervention, participants are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS
* Diagnosis of invasive gynecologic malignancy stages 1-4.
* New patient in the Gynecologic Oncology Center.
* Adequate capacity to understand and complete MPOAD in the opinion of the study investigator or research assistant.
* Able to speak and understand English and/or Spanish.
* Provision of Institutional Review Board (IRB)-approved informed consent.
* Available MPOA or primary family caregiver who consents to study participation.
* FAMILY CAREGIVER/MPOA
* MPOA or if none documented in electronic health record (EHR), primary family caregiver, as designated by the patient.
* Permission to contact provided by patient.
* Adequate capacity to understand and complete study measures in the opinion of the study investigator or research assistant.
* Provision of IRB-approved informed consent.

Exclusion Criteria:

* Without a MPOA or available family caregiver.
Paraffin Bath Therapy for Chronic Hand Eczema

Objective: Chronic Hand eczema (CHE) is a common inflammatory skin disease has a major medical psychological and socio-economic implications that affect quality of life (QoL)and work ability. This study, the first randomized controlled trial that will be conducted to evaluate the effect of paraffin bath therapy (PBT) in the treatment of CHE.

Design: The study design is a randomized controlled trial with measures at pre-and post-intervention.

Subjects: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group.

Interventions: Paraffin group will receive Paraffin bath therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will receive routine skin care program.

Outcome Measures:

Objective SCORing Atopic Dermatitis, subjective item score and dermatology life quality index (DLQI) will be assessed before, at 6th week and at 12th week of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20-40 years
* Time elapsed from the beginning of the disease ; more than three months according to the Guideline of the German Dermatological Society

Exclusion Criteria:

* active eczematous lesions on other parts of the body;
* malignant or premalignant skin tumors
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.

Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.

Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.

Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. HF New York Heart Association classes: II-IV.
2. Life expectancy of more than 6 months.
3. PHQ-9 score ≥10.
4. Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.

Exclusion Criteria:

1. Imminent danger to self or others.
2. Cognitive impairments with a MOCA score of \< 23.
3. Bipolar, Psychotic, and Substance-induced Disorders.
4. Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents

Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Between 8-18 years old
* BMI ≥95th percentile
* Patient \& parent/guardian consent to participate
* Attendance of Risk Factor Reduction lifestyle modification program

Exclusion Criteria:

* Major surgical Procedure within 1 year
* Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
* Mentally Challenged
* Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
* Diabetes
The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time

This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes
* Aged 18 or above
* Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases
* Voluntary and signed informed consent to participate
* Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions

Exclusion Criteria:

* Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm).
* The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor.
* MRI is required during the study.
* The examinee had poor compliance and could not continue to complete the study.
Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer

This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
2. Patients with primary colorectal lesions removed, and negative extrahepatic metastasis
3. Patients with at least one measurable liver metastases, with size \> 2cm or less than 5 liver metastases,with size smaller than 10cm.
4. Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
5. No intervention therapy was received for liver lesions during one year.
6. Life expectancy of \> 3 months
7. Child-pugh's grade A or B (no more than 7 score).
8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2
9. Signed, written informed consent

Exclusion Criteria:

1. Patients with extrahepatic metastasis
2. Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
3. With obvious arterio-venous fistula
4. Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
5. Hematologic function: leukocytes \<3000cell/mm3, platelets\<50000/mm3, with no hypersplenism.
6. Adequate renal function (creatinine ≤ 2.0mg/dl)
7. Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) \>5 times upper limit of normal(ULN)
8. International Normalized Ratio (INR) \>1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
9. With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
10. With recent infections and received antibiotics.
11. Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)

A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG


Eligibility Criteria:
Inclusion Criteria:

Patients of either sex will be eligible for the study if all of the following criteria are met:

1. Patients must be aged 18 years or more.
2. Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
3. The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
4. Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
5. Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
6. Patients must be mentally competent and willing to provide informed consent.
7. Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.

Exclusion Criteria

Patients will not be eligible for the study if any of the following criteria are present:

1. Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
2. Patients with clinically significant corneal disease including corneal dystrophy.
3. Patients with iridocorneal endothelial syndrome.
4. Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
5. Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
6. Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
7. Patients with a history of extensive keloid formation.
8. Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.
9. Patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device.
10. Patients who are unable to interrupt their anti-coagulant, anti-platelet or NSAID (including aspirin) therapy for at least 3 weeks prior to surgery.
11. Patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).