cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent and return for all study visits
* Photopic pupil diameter \<= 3.5 mm in each eye

Exclusion Criteria:

* Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
* History of benign prostatic hyperplasia
* Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
* History of closed-angle glaucoma
* Anatomically narrow anterior chamber angles
* Ocular surgery or laser treatment of any kind
* History of chronic or acute uveitis
* History of traumatic iritis or hyphema
* History of traumatic mydriasis or angle recession
* History of heterochromia
* Irregularly-shaped pupil secondary to ocular trauma or congenital defect.
* History of neurogenic pupil disorder
* History of anterior chamber intraocular lens (IOL) or iris-fixated IOL
* History of iris surgery, iris atrophy, or iris-cornea apposition/touch
* Unwilling or unable to discontinue use of contact lenses at treatment visits.
* Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
* Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
* Pregnancy or lactation
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum Chitotriosidase Level in Psoriasis

The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum Chitotriosidase level in psoriatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe plaque psoriasis of any age and gender.

Exclusion Criteria:

* History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
* Pregnancy and lactation.
* Infections.
* Patients with chronic diseases: hepatic disorders, hematologic diseases, chronic renal failure or cancer.
Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery

Treating pain, just as treating other medical conditions, depends on accurate assessment of patient's condition. When assessing pain, as other subjective symptoms, the challenge is twofold because the assessment is dependent on patient's understanding and use of the scale, all the more so in children

So far, attempts to improve pain assessments have been focused on the development and refining pain scales. No emphasis has been placed on improving patient's ability to report their pain. Our purpose is to evaluate a training program designed to improve the quality of children's post-surgical pain intensity reports.

After receiving Helsinki approval, eligible children and their parents will signed informed-consent. After surgery, the children, their parents, and the department nurses will assess children's pain intensity. Immediately after the nurse assessment, parents will assess their child's pain (blindly and independently) and the children will report their pain on four different pain scales.

Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be invited to participate. Children in the experimental group will be exposed to a training program, developed for this study, aimed to teach and train how to report pain. The control group will receive the standard pre-surgical instructions.


Eligibility Criteria:
Inclusion Criteria:

1. children at age 8-17 years;
2. absence of psychiatry, cognitive, and/or neurological disorders;
3. understand the purpose and the instructions of the study, agree to participate and parent signed inform consent.

Exclusion Criteria:

1. children suffering from Post traumatic stress disorder.
Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients

Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)\* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)\*\* from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.

α risk of 0.05, Statistical power of 80%

Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)

Eligibility Criteria:
Inclusion Criteria:

* Shock patients (hypotension with signs of poor tissue perfusion)

Exclusion Criteria:

* Age \< 18 yr
* Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) \< 35%),
* Prolong shock \>24 hrs,
* Received chloride rich crystalloid (0.9% saline) or chloride rich colloid \> 1000 ml within 72 hrs before recruitment
* Do-not-resuscitation patients,
* Contraindication for IV fluid administration such as pulmonary edema.,
* Stage V chronic kidney disease (CKD),
* chronic Hemodialysis or Peritonealdialyse
Local Opera Viewing Combined Medical Gymnastics for Elderly PSCI

local opera viewing combined medical gymnastics for elderly PSCI

Cognitive impairment and hemiplegia are the two major problems faced by elderly patients with cognitive impairment after stroke. The application of local drama viewing and combined medical gymnastics training aims to improve sports and cognitive function. Local drama viewing and medical gymnastics training integrates drama art cognition and medical sports, is a beneficial scientific attempt.

To construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety.

Eligibility Criteria:
Inclusion Criteria:

Stroke patients who were hospitalized in the Department of Neurology of Zhangzhou Hospital and met the PSCI diagnostic criteria of the Expert Consensus on the Prevention and Treatment of Cognitive Impairment after Stroke in China were the subjects of the study. ① Stroke patients confirmed by neuroimaging, onset time within 1 week; (2) Cognitive impairment occurs after stroke events; ③ The scores of the simple mental state examination scale were points in the illiterate group, points in the primary school group, points in the secondary school group, and points in the college group; ④ can maintain independent sitting position ≥30 min; ⑤ Age ≥60 years old; ⑥ Volunteer to join the study and receive intervention treatment.

Exclusion Criteria:

* Other causes affect or lead to cognitive impairment, such as consciousness disorder, malignant tumor, severe liver and kidney insufficiency; ② There are serious cardiopulmonary and other systemic diseases; Visual or hearing impairment; ④ have emotional behavior abnormalities and mental illness (including depression); ⑤ A history of alcohol or drug abuse
Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML

Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnoses candidates with acute myeloid leukemia.
* Lower than or equal to 18 years-old;
* Subjects are able to provide written informed consent.

Exclusion Criteria:

* Subjects who cannot comply with the study;
* Subjects with severe cardiac disease (ejection fraction\<50% ), liver disease (total bilirubin \>34umol/L, ALT and AST\>1.5×upper limit normal) or kidney disease (Serum creatinine\>130umol/L).
* Subjects with severe infection.
* Subjects with other conditions that cannot receive chemotherapy or transplantation.
Symptom Management Program for Hemodialysis Patients

Self-management intervention may decrease symptom burden and improve functioning over time.

Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old,
2. on HD three times a week,
3. received HD for ≥ six months,
4. read and write English,
5. have telephone service.

Exclusion Criteria:

* history of dementia,
* acquired immunodeficiency syndrome (AIDS) and active cancer, and
* inability to give informed consent.
Energy Expenditure of High Intensity Functional Training

The purpose of this study is to assess the energy expenditure and intensity of a High Intensity Functional Training (HIFT) session in overweight and obese adult men and women.

High Intensity Functional Training (HIFT), which alternates short periods of intense exercise using varied, multiple-joint movements, with less-intense active recovery periods, may offer an attractive, time efficient alternative to traditional aerobic exercise. Variations of HIFT such as Cross Fit, home workout videos (ie.P90x and Insanity), and boot-camp style group exercise classes have become increasingly popular.

The cardiovascular benefits of HIFT have been demonstrated; however, by doing this study researchers hope to get more information regarding the potential effectiveness of HIFT for weight management, such as the actual level of energy expenditure and exercise intensity elicited by a HIFT session.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 25.0 and 39.9
* Currently participating in HIFT (boot-camp) classes at Kirmayer Fitness Center
Esophageal Balloon Calibration in Assisted Ventilation Mode

Esophageal balloon calibration (EBC) has been proposed during controlled mechanical ventilation in intubated patients in order to optimize esophageal pressure (Pes) signal. Actually, at our knowledge, no data exist about EBC during assisted ventilatory modes such as Pressure Support Ventilation (PSV). The primary endpoint of the present investigation is to assess the feasibility of EBC during PSV and PSV plus Sigh.

Assisted ventilatory modes, nowadays, have been proved to reduce complications related to controlled mechanical ventilation. With these modes, ventilatory cycling is under the patient's control to an extent depending on the type of ventilatory modality.

Sigh improves oxygenation and lung mechanics during pressure control ventilation and pressure support ventilation (PSV) in patients with acute respiratory distress syndrome.

In order to better quantify the effects of both PSV and PSV plus Sigh on respiratory mechanics, the esophageal pressure monitoring could be helpful. However, esophageal pressure (Pes) assessment requires esophageal ballon calibration (EBC) as demonstrated in intubated patients under controlled mechanical ventilation.

At our knowledge, no data exist about EBC during assisted ventilatory modes. The primary aim of the present study is to evaluate the effects of PSV and PSV plus Sigh ventilation on esophageal balloon best volume in patients admitted to the intensive care unit for acute respiratory failure.

.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years;
* undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation;

Exclusion Criteria:

* severe COPD with air trapping clinical suspicion;
* hemodynamic instability requiring inotropic or vasopressor support;
* any contraindications to esophageal catheter positioning
Strengthening Community Addiction Services in Vietnam

This study aims to develop and test an intervention to enhance the addiction service continuum with the joint effort of commune health workers and family members of people who use drugs in Vietnam.

The study will develop and test an intervention to strengthen a continuum of addiction services. The intervention, entitled "Community Care Consortium (CCC)," features community health workers' joint effort with family members to provide patient-centered, individualized addiction care and support. The intervention will be developed and tested through three phases in three regions of Vietnam (Ninh Binh, Da Nang, and Can Tho).

In Phase 1, we will conduct formative studies with commune (community) health workers (CHW), community representatives, PWUD, and their family members to identify barriers to addiction service utilization and discuss potential strategies to establish a continuum of addiction services. Based on the formative study findings, the CCC Intervention and its implementation plans will be developed through workgroup meetings with researchers, community members, and target users.

In Phase 2, the CCC Intervention will be piloted in three communes and revised based on acceptability/feasibility data, process evaluation, and feedback from field staff and participants.

In Phase 3, a randomized controlled trial of the CCC Intervention will be conducted in 60 communes, which will be randomized to either an intervention condition or a control condition (30 communes in each condition). A total of 720 PWUD, 720 of their family members, and 180 commune health workers (CHW) will participate in the study. The intervention outcomes on PWUD, CHW, and family members will be assessed with the data collected at baseline, 3-, 6-, 9- and 12-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Having a history of drug use
* Having disclosed drug using status to at least one of his/her family members and is willing to invite this family member to our study
* Currently residing in the selected communes
* Voluntary written informed consent

Exclusion Criteria:

* Inability to give informed consent
Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform

Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System (PROMIS). By the end of the grant period in July 2013, the project team had successfully developed and initially validated eight scales measuring the most common GI symptoms.

Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm which is delivered via My GI Health, an open--source Internet based patient-provider portal (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers, tablets or smart phones without the constraints of physical locale. This information is condensed into a GI PROMIS scores report and initial GI history that patients' providers can review prior to or concurrent with seeing the patient. The report, which can be incorporated into the electronic health record (EHR), helps busy clinicians to quickly understand the patient's complaints, document their symptoms and GI history, and leaves more time for conversation with the patient.

Beyond focusing their interaction, My GI Health also supports both the clinician and patient with an individualized "educational prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments also contained within the website. The prescription is initially created by the website based on each patient's unique GI PROMIS "fingerprint", and can be modified by the provider based on their interaction with the patient. The clinician and patient can also access the PROMIS-tailored education in the exam room to jointly review pertinent materials, including animations of normal and abnormal GI functions, further reinforcing the patients' educational experiences around the PROMIS symptoms.

The aim of this current study is to validate the use of GI PROMIS in clinical practice by conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel e--platform vs. usual care.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to the gastrointestinal clinic for evaluation.
* Able to read and write English.
* Has basic computing skills.

Exclusion Criteria:

* Having been seen and evaluated in the gastrointestinal clinic within the last 8 months.
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥18 years；
2. Established or clinical diagnosis of candidemia and/or IC ；
3. Present of 1 or more systemic signs attribute to candidemia and/or IC 4 days prior to randomization;
4. Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment；
5. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis；
2. Severe hepatic impairment in subjects with a history of chronic cirrhosis；
3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement;
4. Laboratory abnormalities in baseline specimens obtained at screening;
5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening;
6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \>48 hours;
7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;
8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;
9. Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;
10. Females who are in gestation or lactating period or planned pregnancy during the study
11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;
12. In the judgment of the Investigator, other reasons unsuitable for study.
A Trial of Esophageal and Gastric Stenting for Leak or Perforation

Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.

This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the stent.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
2. Patients will be required to undergo imaging with CT scan, endoscopy, or fluoroscopy to investigate the leak. Once the location of the leak is identified, then patients must be taken for stenting and any adjunctive treatment within 12 hours of diagnosis or within 12 hours of arrival to The Methodist Hospital.
3. Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.

Exclusion Criteria:

1. Patients who will not agree to return for routine follow-up and studies.
2. Patients who will not tolerate an endobronchial ultrasound or endoscopic procedure (coagulopathy \[INR\>1.8, PTT\>60, or platelet level \<50\], hemodynamically unstable \[MAP\<50 or SBP\<80\], or other medical illness precluding safe endoscopy).
3. Patients who have a perforation too high to stent (such as the back of the pharynx, where a stent is not able to be placed), the only unfavorable anatomic location is this one listed above; we believe all other locations are amenable to stent placement.
4. Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.