cyrilzakka/clinical-trials huggingface dataset:
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children

This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.

30 participants with normal binocular vision and 30 with CI will be recruited for this prospective study. All participants with CI will be treated with 12 weeks of office-based vergence/accommodative therapy. The primary outcome measure will be the average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence will be time to peak velocity, latency, and accuracy. Changes in clinical measures \[near point of convergence (NPC), positive fusional vergence at near (PFV)\] and symptoms will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* CI Symptom Survey score ≥ 16
* Exophoria at near at least 4 greater than at far
* Receded near point of convergence (NPC) of 6 cm break
* Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion or PFV ≤15 base-out break)
* Best-corrected distance visual acuity of 20/25 or better in each eye
* Random dot stereopsis appreciation of 500 seconds of arc or better
* Wearing appropriate refractive correction (spectacles of contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)
* No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study

Exclusion Criteria:

* Constant strabismus at distance or near
* Esophoria of ≥ 2∆ at distance
* Vertical heterophoria ≥ 2∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \>20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* History of strabismus surgery or refractive surgery
* CI associated with head trauma or known disease of the brain
* Diseases known to affect accommodation, vergence, or ocular motility
* Inability to comprehend and/or perform any study-related test
8.4% Sodium Bicarbonate Locks in Intestinal Failure

We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.

Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
* Subject is less than 18 years of age at the time of study entry
* Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)
Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.

This study aims to describe the safety, tolerability and adherence to the coformulated anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines. Three or two anti-HIV drugs are administered for 28-days depending on the severity of the the assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP. Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since 2006.

This is a multi site, prospective, open-label, non-randomised trial. Participants will be MSM who present at the various recruitment sites requesting NPEP. Initially, 50 eligible participants will be assigned to receive eviplera 25mg once daily taken with food for 28-days according to established Australian guidelines for the use of 3-drug NPEP. There will be 7 visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim analysis demonstrates acceptable safety, it is proposed to seek ethics approval to increase the samples size to 100 patients to gain more accurate information on regimen completion rate and on-drug adherence.

The primary study objectives are:

1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF
2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF
3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using FTC-RPV-TDF


Eligibility Criteria:
Inclusion Criteria:

1. Man who has sex with men
2. Age at least 18 years
3. Eligible for 3-drug NPEP according to Australian guidelines for the use of 3-drug NPEP following an actual or potential sexual exposure to HIV or receptive anal intercourse with an unknown source
4. Able to provide written, informed consent
5. Able to commit to the study visits

   Exclusion Criteria:
6. Non-sexual exposure
7. Exposure occurring during sex between a man and a woman
8. HIV infection diagnosed on day 1 serological testing including indeterminate serology consistent with possible primary HIV infection
9. Use of any medication contraindicated with FTC-RPV-TDF
10. Serum hepatic transaminase (alanine aminotransferase \[ALT\] greater than 5 times the upper limit of the normal range
11. Serum estimated Glomerular Filtration Rate (eGFR) \<60mL/min/ BSAc
12. Current therapy for hepatitis B
13. Day 1 serological evidence of chronic/active hepatitis B
14. Previous NPEP containing FTC-RPV-TDF
15. A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
Park Rx and Physical Activity Among Low-income Children

This study is a randomized controlled trial to evaluate ParkRx, a clinic-based counseling intervention in which health care providers prescribe park visits at a specific frequency, duration, and includes instructions for physical activity in the parks. We will assess whether prescribing visits to specific parks changes physical activity levels and improves health and mental health outcomes among low-income pediatric patients.

Park prescriptions are formal clinical encouragements for patients to engage in more physical activity outdoors. From the beginning, ParkRx has been perceived as a common-sense solution to physical inactivity and to increasing the time children might be spending outdoors in nature. In spite of a lack of rigorous evidence that it is effective, the ParkRx concept is currently being widely disseminated and has been embraced by multiple national organizations. Unity Health, a federally qualified community health center in Washington, DC, is currently implementing park prescriptions for its largely low-income and minority population, a group at high risk of chronic diseases, physical inactivity and obesity. In partnership with Unity Health, we propose to conduct a randomized controlled trial (RCT) to prospectively evaluate Park Rx's impact on physical activity, as well as other secondary health outcomes in pediatric patients. Our specific aims are: 1) to test whether Park Rx will increase park visits and accelerometry-measured physical activity among children; 2) to identify any biological impacts of Park Rx on health, including impact on hypercholesterolemia, hypertriglyceridemia, HbA1C, overweight and obesity, for those patients with relevant diagnoses; 3) to explore impacts on mental health, including stress and measures of cognitive functioning; and 4) to determine whether there are age and gender differences in adherence to and impact of Park Rx. The results of this study will quantify the effectiveness of Park Rx and inform its future dissemination.

Eligibility Criteria:
Inclusion Criteria:

* ages \>6 and \<16 with one or more diagnoses of chronic conditions that usually require two or more routine health care provider visits per year.
* ADHD, or
* Overweight or obesity, or
* hypertriglyceridemia or
* hypercholesterolemia, or
* pre-diabetes or
* Type 2 diabetes. AND
* Likely to live in the Washington DC area in the next 2 years.

Exclusion Criteria:

- Individuals who have previously been given a park prescription
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function

This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and at specified intervals after dosing and the concentration of MNTX will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 18-80 years
2. Body weight greater than 100 lbs and BMI between 18-38
3. Liver values that are abnormal must not be clinically relevant as judged by the investigator. Liver enzyme and bilirubin must be less than 5 times the upper normal of reference range and may be repeated under fed conditions if abnormal. Stable hepatitis patients as well as cirrhosis patients of either etiology.

Exclusion Criteria:

1. History of current alcohol abuse with less than 1 year abstinence
2. Conditions possibly affecting drug absorption, e.g. gastrectomy or clinically significant diabetic gastroenteropathy.
3. Currently pregnant or nursing
4. Methadone use.
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway

Clinical follow-up survey of the Norwegian material of paediatric patients who received therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life, education, work, family and children, delayed effects of tumour disease and treatment, endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.


Eligibility Criteria:
Inclusion Criteria:

* Whose who has been treated for medulloblastoma og CNS-PNET between 1974 and 2013

Exclusion Criteria:

* Other brain tumours
Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were recommended the perioperative nutrition for malnutrition patients. But in our hospital, there are no consensus guideline applied for the clinical practice. The nutritional supplement was judged by only attending physical This study was conducted to comparing the perioperative nutritional supplement with oral supplement with conventional approach with only dietary advice alone for all patients who undergoing major gastrointestinal surgery.

The study design is a randomized controlled study. The eligible criteria is all patients who undergoing major gastrointestinal surgery including upper/lower gastrointestinal tract and hepatobiliary and pancratic surgery. After the informed consent are obtained. The patients are randomized into two group (study group and conventional group). The perioperative supplement with oral nutritional support and dietary advice were assigned in the study group. The conventional group were assigned only dietary advice. The blood test and nutritional assessment are performed by investigators in all participants. The participants were assessed two times before the operation (at first assigned and the day before the operation). The duration of nutritional supplement is at least fourteen days.The patient characteristic data, surgical intervention, and postoperative data were collected. The main outcome is the postoperative morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 year
* undergoing major gastrointestinal surgery
* able to take oral diet

Exclusion Criteria:

* unable to take oral diet
* Gastrointestinal tract insufficiency eg. gastrointestinal obstruction, perforation, malabsorption and peritonitis
* allergy to milk
* history of previous nutritional supplement from other source within one months
* chronic kidney disease (eGFR \< 60 ml/min/1.73 m2)
* Take preoperative supplement less than 14 days
* Refused or withdraw from the study
Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit

To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient is admitted to ICU with APACHE-II score more than 15
* Subject is 18 years old and older on the day of the first dosing
* Subject with evidence of proven or probable IFI defined by modified criteria of European Organization for Research and Treatment of Cancer(EORTC)

Exclusion Criteria:

* patient is known to be hypersensitive to caspofungin
* patient's Child-Pugh score is more than 9
* patient is prone to discontinue treatment result from lack of cost
* patient or their guardian refuse to sign a informed consent form
* patient concurrently receiving efavirenz, nevirapine, rifampin, systemic dexamethasone, phenytoin, carbamazepine, phenobarbital, or cyclosporine and other agents have influence on PK parameters of caspofungin
* patient is treated with caspofungin within 24 hours
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).

This study seeks to further develop the use of NIRS technology in the diagnosis of acute compartment syndrome. NIRS values normally increase in traumatized legs compared to the contralateral uninjured leg or forearm, indicative of a hyperemic response. The investigators hopes to build upon the current knowledge and verify the ability to accurately detect ACS using two easily identified and accessible leg compartments, the anterior and superficial posterior utilizing the Nonin 7600 oximeter with the Sensor Model 8004CV. Additionally, since this device was originally designed with brain tissue in mind, the NIRS device will collect vital engineering data that will be used to validate the algorithm used to produce the oxygenation values in injured muscle tissue.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral leg injury
* Enrolled within 48 hours of injury
* Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below:

Anatomic location:

* Tibia/Fibula shaft fracture
* Tibial plateau fracture (Schatzker III-VI)

High Energy Mechanism of Injury:

* Fall from \>8 foot height
* Motor vehicle collision (\> 15 mph)
* Motor vehicle versus pedestrian accident
* High velocity gunshot wound
* Crush injury
* Sport/recreation

Exclusion Criteria:

* Application of NIRS monitoring would be an impediment to care
* Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment
* History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery
* Admission for atraumatic medical reasons
* Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative
* Complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity
* Patients who are in police custody at presentation to the hospital or who are pregnant
* Patient has an open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment
* Bilateral leg injuries
* Not able to be enrolled within 48 hours after injury
A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer

This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject with histologically proven, locally advanced or metastatic NSCLC for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a local laboratory.
* Subject has measurable disease according to RECIST v1.1. For phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable.

Exclusion Criteria:

* Subject with unstable or progressive central nervous system (CNS) metastases.
* Subjects with clinically significant cardiovascular disease.
* Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
* Subject is pregnant or lactating.
Impact of Expanded Peri Operative Warming

The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.

This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.

This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are adult patients 18 years and older elective surgery of \> 1 hour

Exclusion Criteria:

* Emergency and/or trauma cases
* Patients with diminished mental capacity unable to fill out or respond to survey questions.
Nitrate Patch Use as Treatment of Knee AVN

The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.

This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.

The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.

This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.

The following outcomes will be measured:

* MRI findings before and after the patch treatment
* Use of analgesics
* Subjective pain relief.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18-80 y.o)
* diagnosis of AVN according to MRI

Exclusion Criteria:

* Terminal illness
* Cognitive impairment / any condition disturbing informed concent.
* Nitrate intolerance
* Patients using Cyclic GMP inhibitiors
Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

The purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.

Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. Past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. Does exercise differentially act on various risk factors in the same subject? Do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? To our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs.

Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month period. The second 6-month period is for follow-up and other purposes.

Eligibility Criteria:
Inclusion Criteria:

Body mass index (BMI) of 24.2-34.9 with 2 or more of the following risk factors:

* Resting systolic blood pressure of 130-179 mmHg
* Fasting blood glucose of 110-139 mg/dl, or HbA1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl
* LDL-cholesterol of 120-219 mg/dl

Exclusion Criteria:

* Diastolic blood pressure of 110 mmHg or greater
* History of clinical heart disease or stroke
* Orthopedic problems that might interfere with exercise
* Dementia
* Abnormal exercise EKG test results
* Private physician's disapproval