cyrilzakka/clinical-trials huggingface dataset:
Inhaled NO in IPF and COPD During 6 Minute Walk Test

Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo.

This is a randomiized, placebo controlled trail that will evaluate the influence of inhaled NO (INO) on the saturation and exercise capacity of patients with COPD and IPF. All patients will sign a consent form before enrolment. Each patient will undergo two six-minute walk tests. Whether the INO will be used in the first or the second trial will be determined by computer generated randomization with random numbers sealed in opaque envelops. For the placebo 6-minute test we will use placebo cartridges in the INO generator, for INO 6-minute test we will use NO cartridges. The treatment with INO or placebo will start 20 minutes before the 6-minute walk test and will end at the end of the 6-minute walk test. Between tests a time interval of at least 60 minutes will be kept. During the test, the patients' pulse and saturation level will be monitored with a pulse oximetry. The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that require supplemental oxygen will perform the tests with oxygen supplementation.

Dosing The NO dosing will be fixed. The first 10 patients will be treated with INO at a dose of 45 parts per million (ppm) per kilogram (kg). from patient 10 to 20 a dose of 75 ppm per kg will be given and from patient 20-100 a dose of 115 ppm per kg will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with COPD with disease severity of GOLD stage 3-4
2. Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60%
3. Ambulatory patients that can perform a 6-minute walk test

Exclusion Criteria:

1. Patients with moderate to severe heart failure - EF \< 40%
2. Patients with severe PVD or scleroderma
Field Implementation of iDETECT

The purpose of this study is to assess a new screening tool for sideline evaluation of concussion injuries in athletes. iDETECT is a new technology that combines several elements of recommended concussion screening tools into a single, portable device.

The goal of the research is to evaluate the use of a multimodal platform (iDETECT) for immediate post-injury neuropsychological, balance and oculomotor assessment, and to evaluate the iDETECT platform as a return-to-play assessment tool during the post injury management period following concussion.

Eligibility Criteria:
Inclusion Criteria:

* Athletes participating in the Fall 2015 high school season
* Aged 14 years or older
* No concussion injuries within prior 2 months
* Provide signed and data consent and/or assent form(s)

Exclusion Criteria:

* Non-English speaking
* History of seizures or prior brain surgery (excluding facial and TM surgery)
* Concussion within last 2 months
* Poor Effort on baseline iDETECT test

Non-Collision Sport Group

* current concussion or history of current concussion during the Fall 2015 athletic season
A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.

This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
* For Expansion : Histological or cytological confirmation of
* Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
* Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
* For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks
* For Part B : Child-Pugh liver function status classified as A to B7

Exclusion Criteria:

* For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
* With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
* Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
* Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
* Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)
Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)

The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Subjects with Chronic Obstructive Pulmonary Disease (COPD).

This real-world study is a multi-centre, single-cohort, ambi-directional observational cohort study with both retrospective and prospective data collection, with the primary objective to assess the 12-week effectiveness of BDP/FF/GB for COPD subjects in China. The index date is the initiation date of BDP/FF/GB, and subjects may have initiated treatment with BDP/FF/GB up to 12 weeks before enrolment. Baseline period is the 12 weeks prior to index date. The end of study (EOS) for each subject will be the earliest of the following: approximately 12 weeks after BDP/FF/GB initiation (the Week 12 Visit), BDP/FF/GB discontinuation plus 2 weeks, or at early withdrawal (such as consent withdrawal, death, or lost to follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are willing and able to give their written consent to participate in the study
2. Aged ≥40 years at BDP/FF/GB initiation
3. Had documented diagnosis of COPD prior to BDP/FF/GB initiation
4. Baseline CAT total score ≥10 (at the time of BDP/FF/GB initiation OR within the 12 weeks prior to treatment initiation, if no CAT total score is available on BDP/FF/GB initiation date)
5. Subjects who have initiated treatment with BDP/FF/GB within 12 weeks prior to informed consent form (ICF) signature, or on date of ICF signature

Exclusion Criteria:

1. Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
2. Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
3. Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
4. Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation
Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio

The present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS).

We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.

The present study aims to evaluate the relationship between MHR, metabolic parameters and the percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve gastrectomy (LSG).

This prospective cohort study will evaluate obese participants undergoing LSG. Demographic data of the participants and blood glucose level, monocyte count and lipid parameters baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after surgery and the %EWL at 6 months after surgery will calculate. The participants will be divide into two groups as participants with %EWL of \<50 and patients with a %EWL of ≥50. The parameters will compare between the two groups.

Eligibility Criteria:
Inclusion Criteria:

Obese patients (BMI ≥40 or \>35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy.

Exclusion Criteria:

Receiving antihyperlipidemic therapy, Important complications that continue within 6 months after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue infection) Did not attend 6-month control visit were excluded from the study.
Buspirone for Functional Dysphagia

This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.

Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry).

Our two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills.

We hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above
* Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction
* Esophageal biopsies negative for eosinophilic esophagitis

Exclusion Criteria:

* Pregnant women
* Prisoners
* Currently on other serotonin modulating medications
The Effect of Increased Physical Activity on Adolescents' Health and Academic Performance: The School in Motion Study

This study evaluates the effect of 120 minutes extra of physical education (PE) or physical activity (PA) on adolescents' physical health, mental health, academic performance and learning environment. This is a cluster-randomized controlled trial with three arms, where the participants in two of the groups will have different models of increased PE/PA during the school week, whereas the participants in the third arm is the control group including current practice.

This is a school-based, three-arm cluster randomized controlled trial (RCT) recruiting adolescents from secondary schools in Norway. Adolescents (aged 14-15 years) were the unit of analysis, and schools (clusters) were randomly assigned to one of three conditions:

1. the physical active learning group (PAL-group), where the schools each week include one additional physical education (PE) lesson, 30 minutes of physical active learning, and 30 minutes of physical activity (intervention condition);
2. the don't worry - be happy group (DWBH-group), where the schools include one new activity class (60 minutes: Be Happy class) and one additional PE-class (60 minutes: Don't Worry class) per week (intervention condition);or
3. current practice (control condition). An identical set of outcome measures are taken from all participants at baseline, and approximately 12 months after the baseline measures, when the participants were at the end of year 9

Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled in 9th grade

Exclusion Criteria:

* None
Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders

This study will determine the feasibility of offering expanded continuous labor support by trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant women receiving care for substance use disorders (SUD). The long-term goal of this transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral health disparity in the state. This cross-campus multi-disciplinary collaboration, is in partnership with Young Women United (a research and policy organization in NM) and doulas of the UNM Birth Companion Program. Through this partnership, women receiving combined OB/SUD treatment at the Milagro Program at UNMHSC will be offered expanded doula services.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* able to participate in informed consent
* able to read, write, and speak English
* gestation of at least 26 weeks at baseline (necessary because of short duration of study)
* plan to give birth at UNM.

Exclusion Criteria:

* active psychosis
* current incarceration
* identified by medical staff as unable for medical reasons to currently participate in the study
* not interested in having doula support
Sulodexide Treatment in Patients With Dense Deposit Disease

The purpose of this study is to see if a medicine called Sulodexide will help prevent or slow down the progression of Membranoproliferative Glomerulonephritis type II/Dense Deposit Disease. Sulodexide is not yet FDA approved and has not been studied in children.

Study aim/hypotheses: to measure the efficacy of Sulodexide treatment in patients with the above disease/s.

Study subjects will be asked to take Sulodexide twice a day. The Sulodexide will be taken in addition to the regular medications the subject is on. There will be no change in these other medications. The subject will also be asked to have blood tests each month to follow kidney function. The frequency of these tests is the normal/standard frequency for persons with MPGN II/DDD and is neither increased nor decreased because of participation in this study. The study will occur over 6 months for each subject.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 5 yrs. to 20 yrs. old
2. Patients must have Membranoproliferative Glomerulonephritis Type II (MPGN2), also known as Dense Deposit Disease (DDD)

Exclusion Criteria:

1. Patients less than 5 years of age or older than 20 years of age
2. Patients who DO NOT have a diagnosis of Membranoproliferative Glomerulonephritis (MPGN 2) also known as Dense Deposit Disease
3. Evidence of hepatic dysfunction including total bilirubin \>2.0mg/dL (34 micromol/L) or liver enzymes \>3 times upper limit of normal.
4. A history of any major medical condition (excluding DDD), including but not limited to: gastrointestinal bleeding in the past 3 months; HIV; active Hepatitis B or C (current active disease defined as an abnormal liver biopsy or persistent, elevated transaminases, SGOT, SGPT); and other medical conditions deemed serious by the investigator
5. any risk of bleeding, including a history of bleeding diathesis and a platelet count \<100,000/mm3
6. active cancer
7. Participation in any experimental drug study in the 60 days prior to entry into this study; or plan to participate in any experimental drug study during the study period.
8. Known allergy or intolerance to any heparin-like compounds
9. Inability to give an informed consent or cooperate with the study personnel -
Dry Needling Treatment for Biceps Tendinopathy

Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.

We will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN.

Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Common symptoms are pain in the anterior shoulders and radiating pain in the biceps. Pain can be further elicited with lifting, pulling and repetitive overhead activity. Therefore, it can have a major impact on the patient's activity of daily life.

The investigator performed dry needle (DN) treatments with acupuncture needles. Stimulating the effected muscle , the investigator move the needle forward and backward several times. Muscle twitch may occur by our procedure. The pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.

The investigator will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of DN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluation of biceps peritendinous effusion.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects older than 20 years of age who can cooperate with the experimental volunteers.
2. Suffering from biceps tendon lesions for more than one month, and subjective pain intensity (VAS) greater than 5 points.
3. There is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain.
4. Under soft tissue ultrasound, the thickness of Biceps Peritendinous Effusion (BPE) on the affected side of the biceps tendon is greater than 1 mm.

Exclusion Criteria:

1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
2. There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
3. Have received shoulder, neck or upper back surgery.
4. People with central or peripheral nerve disease.
5. Cognitive impairment, unable to cooperate with the experimenter.
6. Patients currently receiving other treatments for Biceps tendinopathy
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 and older.
* Documented moderate to severe traumatic brain injury at least one year post injury.

Exclusion Criteria:

* The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
* Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
* Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
* Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes

A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing

The null hypothesis would be that the introduction of molecular methods did not statistically affect patient outcomes. To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been treated at SWRWCC during the months of March, April, or May 2010.

Exclusion Criteria:

* Patients who were not treated at SWRWCC during the time frame of March, April or May 2010.
Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects

The purpose of this study is to examine whether ultrasound bone strength device (Model Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of human subjects, compared with a listed, similar device (Model Number: SONOST3000).

This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will be randomly assigned to two different detective sequence groups. In one group, the investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device firstly and then by control device. In another group, the investigators will detect the same calcaneus of each subject by control ultrasound bone strength device firstly and then by experimental device. Experimental ultrasound bone strength device is developed by Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control ultrasound bone strength device which has same clinical indications and action mechanism with the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is SONOST3000.

Eligibility Criteria:
Inclusion Criteria:

* Subject who need to measure calcaneal bone strength index.
* Subject is a male or female subject 20-80 years of age.
* Subject is willing and able to provide signed and dated written informed consent form.
* Subject whose compliance is good and can cooperate to complete the clinical trial.

Exclusion Criteria:

* Subject whose heel skin fester or defect.
* Subject has a history of allergic reactions to ultrasonic coupling agent.
* Subject who is not cooperative obviously or nervous extremely.
* Pregnant or lactating females.
* Subject has a mental disease, without self-control.
* Subject has participated in other clinical trial within a month.