cyrilzakka/clinical-trials huggingface dataset:
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics

This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 18-30 kg/m\^2
* Body Weight 60-80 kg
* Participant with both a normal stomach and proximal duodenum mucosa as evidenced by endoscopic results

Exclusion Criteria:

* Participant with evidence of current/active, or a history of gastrointestinal disease
* Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy
* Participant with a history of using antacids, H2 receptor antagonists, proton pump inhibitors, or misoprostol more than twice a month or has used any of these medications within 1 week of Visit 1.
* Participant with a current or recurrent disease, within 12 months of Visit 1, that could affect the action, absorption, disposition, or excretion of the study treatments or evaluation of the clinical or laboratory tests
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this study is to determine whether OCT-guided settings for the lasers used for removal of corneal scars and other partial-thickness corneal defects result in improved vision in patients receiving these procedures.

The long-term goal of this project is to utilize newly available very high-speed OCT technology to guide surgical treatments of corneas with superficial opacities and irregularities. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain OCT (FD-OCT) technology has made the requisite speed possible.

Eyes with superficial opacities (corneal scars and stromal dystrophies) can be treated by phototherapeutic keratectomy (PTK). Currently, many surgeons rely on subjective slit-lamp impression of opacity depth to guide PTK and repeat slit-lamp examinations during surgery to determine if the opacity has been sufficiently reduced. Unpredictable hyperopic shifts can occur after PTK. The aim of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide surgery. Patients with irregularly shaped corneas could have their vision restored by reshaping the corneas with a procedure that combines the precision of OCT and lasers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vision primarily limited by superficial opacities and irregularities that could be removed by PTK while leaving at least 250 µm.

Exclusion Criteria:

* Inability to give informed consent
* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required visits to complete the study
* Deep corneal opacities and irregularities
* Cataracts, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection

The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.

Introduction: The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months with the standard course for 6 months.

Methods: Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. the group I was assigned to isoniazid (H) at a dose of 300 mg per day for 6 months and the group II was assigned to isoniazid at a dose of 300 mg per day plus rifampin (R) (600 mg per day) for 3 months. The patients were followed for five years.

Results: 105 patients were included, of which 9 refused the treatment; 45 patients were included in the group I and 51 patients in the group II. Both groups were comparable at base level. The hepatotoxicity was 44% in the group 6H and 29% in the group 3HR (p = 0,07). The hepatotoxicity was severe in 6.7% in the group 6H and 5.8% in the group 3HR; these obliged the suspension of treatment in 4.4% and 1.9%, respectively (p =NS). The proportion of patients who completed the study treatment was 75.6% of the patients in the group 6H, and 90.2% in the group 3HR (p = 0,05). Only a case of tuberculosis was detected in the second month treatment with 6H.

Conclusion: In the treatment of latent tuberculosis infection, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.

Eligibility Criteria:
Inclusion Criteria:

* patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:

Exclusion Criteria:

* HIV infection.
* Hepatopathy
* Previous treatment of of latent tuberculosis infection.
* Allergy to drugs.
The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs

Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary women,
* previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping

Exclusion Criteria:

* Lower limb surgery,
* patella displacement
* knee instability
* Heart or locomotor disorders which might influence the evaluation
The Effects of Visior on Ocular Hemodynamics

To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects.

To determine if glaucoma patients and healthy subject experience any alteration in localized retinal blood flow after retinal stimulation by viewing commercially available content through the VISIOR video goggles.

Both groups will undergo measurements of arterial blood pressure, cardiac pulse (heart rate), intraocular pressure, and retinal blood flow using Heidelberg retinal flowmetry (Heidelberg Engineering, Heidelberg, Germany) at baseline and then ten minutes, thirty minutes, and sixty minutes after viewing commercially available content through the VISIOR video goggles for thirty minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.

Exclusion Criteria:

* Women who are pregnant or lactating or who plan to become pregnant (self reporting); smoker during last ten years (self reporting); systemic diseases that may interfere with blood flow measurements or wearing the goggles.
* In addition, 10 healthy subjects, age 18 or older, free from eye disease will be enrolled. Identical exclusion criteria apply to this healthy group. Identical procedures apply to this group, which only differs by ocular health status.
In-Home Technology for Dementia Caregivers

This study aims to develop and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.

This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.

Hypotheses:

1. Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, higher mental and physical health, higher well-being) than those in the limited home safety condition.
2. Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
3. Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers are fluent/literate in English
* Caregivers currently reside with spouse/family member with dementia
* Caregivers primarily use an iPhone
* Caregiver has wireless internet in home

Exclusion Criteria:

* Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
* Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
* Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
* Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
* Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
* Caregivers providing care for individuals with contraindications to MRI imaging
* Caregivers providing care for individuals with large confluent white matter lesions
* Caregivers providing care for individuals with significant systemic medical illness
* Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely

If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.
Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China

This study will be carried out in Liangshan Yi Autonomous Prefecture, Sichuan province, China, using a single-blinded randomized controlled trial design to measure the effects of a mobile-based HIV-related information intervention on group HIV/AIDS prevention. Village doctors will be responsible for sending the HIV-related health education information to the participants. The aim of this study is to develop a generalizable, effective, acceptable, and convenient mobile-based information intervention model to improve HIV-related knowledge, attitudes, practices, and health outcomes in poverty-stricken areas in China and measure the impact of incentive policies on the work of village doctors in Liangshan, China.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* has mobile phone with internet service
* has and use WeChat and TikTok account regularly
* willing to provide informed consent
* speak Mandarin Chinese or Yi ethnic group's language

Exclusion Criteria:

* diagnosed with psychiatric disorders
* diagnosed with severe cognitive impairment
* diagnosed with severe physical disabilities
* has already attended or is currently attending another intervention program
* plan on moving out of Liangshan in the 18-month study period
Comparison Between Infant Flow SiPAP and Noninvasive NAVA in the Neonatal Intensive Care Unit

When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. The breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. A new device called neurally adjusted ventilatory assist or NAVA is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. When using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. The objective of this pilot study is to compare this new breathing device called NAVA, to the equipment that is currently being used, called SiPAP, to support premature newborn's breathing after birth without a breathing tube. The investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid intubation.


Eligibility Criteria:
Inclusion Criteria:

* Infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation
* Diagnosis of RDS in the first 24 hours of life requiring respiratory support
* Parental consent obtained

Exclusion Criteria:

* Infants with a major congenital anomaly
* Infants with pulmonary hypoplasia
* Infants known or suspected to have a neuromuscular disorder
* Infants less than 28+0 weeks GA
* Intubated infants that are likely to require continued mechanical ventilation
* Infants requiring vigorous resuscitation at birth, including chest compressions +/- cardiac medications
Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Non-Alcoholic Fatty Liver Disease

There is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. Currently, there are no studies had been focusing the effect of Modified Alternate Day Calorie Restriction in NAFLD patient focusing on changes in liver steatosis and fibrosis.

Disease activity and progression of non-alcoholic fatty liver disease (NAFLD) to non-alcoholic steatohepatitis (NASH) and cirrhosis can be highly variable, where 2-3% will eventually progress to end-stage liver diseases. With the rising prevalence of metabolic syndrome and obesity, NAFLD has become the most frequent form of chronic liver disease in the West but also in Asia.

There are good evidence that weight loss is effective in improving liver histology in NAFLD, for example, 31 obese patients with NASH was randomised into intensive lifestyle changes over 48 weeks versus structured basic education only, and the intensive lifestyle group showed significant improvements in steatosis, necrosis, and inflammation. Intense calorie restriction is the recommended form of dietary strategy for management of NAFLD. Even though such intense dietary strategy has proven to be effective, some patients find it difficult to adhere and maintain.

On the other hand, intermittent fasting achieves more consistent weight loss by improving adherence, as intermittent fasting only requires calorie restriction every other day compared to conventional form of daily calorie restriction. Alternate day calorie restriction can be divided into two components, a 'feed day' and a 'fast day' where food is consumed ad libitum for 24 hours period alternating with either complete or partial (modified) calorie restriction for the next 24 hours. MACR, the dietary strategy employed in the investigator's study, restricts 70% of an individual's daily requirement of calorie per day. There are other forms of intermittent fasting, for example, 2-4 days of ad libitum feeding alternating with 2-4 days of calorie restriction.

Currently, there are no approved pharmacological therapies for NAFLD, and many guidelines advocate recommendation with a focus on controlling risk factors and lifestyle interventions that include dietary and physical activities. No specific NAFLD trials have evaluated the effectiveness of modified form of intermittent fasting in the control of NAFLD activity.

Eligibility Criteria:
Inclusion Criteria:

* Have elevated ALT or AST level (ALT \>41 or AST\>34 IU/L)
* No evidence of other forms of liver diseases
* For those with diabetes mellitus and dyslipidaemia, they must be on a stable therapy for at least 6 months prior to study enrolment

Exclusion Criteria:

* Significant alcohol consumption (\> 1 standard drink per day)
* Pregnancy
* Involvement in an active weight loss program or taking weight loss medications
* Substance abuse and significant psychiatric problems.
Breathing Parameter Measurements for Lung Deposition Simulation

This study aims to simulate the deposition of aerosol drugs within the airways of asthma and COPD patients based on realistic breathing patterns measured at different pulmonology centers.

Further goal of the study is to find correlations between the amount of drug depositing in the lungs and the measured breathing parameters, as well as disease status and demographic data. The results of the study will be part of a major objective targeting the optimization and personalization of aerosol drug therapy.

The inhalation of aerosol drugs is a key element of current asthma and COPD treatment. The efficiency of the therapy is highly influenced by the dose depositing in the lungs. However, the amount of drug depositing in the lung is a result of complex drug particle-inhaler-patient interaction, thus it is inhaler-, drug- and patient-specific. Assuming that the airflow dependent aerodynamic characteristics of the drugs are known, the lung dose depends on the patient's breathing parameters during the inhalation of drug through the inhaler. In this study the inhalation parameters of asthmatic and COPD patients are measured and lung deposition assessed by a validated numerical lung deposition model. Effects of different breathing parameters (inhalation time, inhaled volume, average flow rate, peak flow rate, time until peak flow rate is reached, breath-hold time) as well as patient demographic data, disease type and disease severity on the lung dose are studied. The correlations are analysed for asthma and COPD groups separately.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed obstructive lung disease (asthma or COPD)
* proper usage of inhalation tool after being educated
* availability of whole body plethysmography measurement data from the last 6 months or the possibility to perform them before the start of the study
* subject under outpatient/inpatient therapy
* capable of acting and cooperating

Exclusion Criteria:

* the patient doesn't align with any of the criteria mentioned above
* the patient is incapable of filling out the questionnaire/questionnaires' parts that are accorded to him/her
* the patient doesn't agree to have data collected of him/her
* diagnosed heavy, not treated chronic illness
* not properly carried out /not evaluable lung function (spirometry) examination
Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients

Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber classification system divides ankle fractures in three types according to the anatomy of lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and internal fixation. However, it's been reported that even with successful reduction surgically great results are not always achieved. Local wound infiltration blocks the pain in its origin, surgical site by itself, without alter motor function. Practically without presenting adverse events with this method. it´s accurate for ambulatory surgery.

Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction and internal fixation.

Method: Two groups with ankle fractures which will be informed and the patients will sign informed consent, after that the patients will be assign to a group (Ropivacaine or bupivacaine). The patient will be prepared for surgical treatment according to his doctor. It will be applied traditional anesthesia. It will be applied before beginning surgery in bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting surgery. After that the patient will have the traditional dose of analgesic treatment.The group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group will register data and will make statistic analysis. It will be elaborated the conclusion an elaboration of a report.

Resources: The group counts with human resources of the group of investigators. The hospital has in emergency department almost three patients with ankle fractures each day which require surgical treatment. The hospital has x ray service to valuate the ankle fracture and with computer system to analyze it. The hospital has the software for statistical analysis.

Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment of ankle fractures. Investigators have the support of pain medicine group in hospital and with anesthesia coordinators. Investigators have a group of orthopedic residents which will be encharged of ilfiltration wound site.

Time: September 2016 to February 2017.


Eligibility Criteria:
Inclusion Criteria:

* Patient with afiliation to IMSS
* Patient with ankle fracture that requires surgical treatment with open reduction and internal fixation
* Patient that accept to participate in the study whit a sign of document.

Exclusion Criteria:

* Politrauma patients (Patients with another fracture)
* Patients who dont accept to participate in the study
* Neuropathy in inferior limps that limits pain perception
* Open ankle fractures