cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH.
2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Under the age of 18 years
2. Difficult venous access
3. BMI \> 40 kg/m2
4. Patients with severe clinical gastroparesis as determined by repeated vomiting
5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
6. Known or history of inflammatory bowel disease or bezoars
7. History of diverticulitis, diverticular stricture, and other intestinal strictures
8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study
9. Be receiving any prostanoid therapy to treat portopulmonary hypertension
10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil
11. Have had a failed kidney transplant within the previous 180 days
12. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results
13. Those with significant cardiovascular disease including treatment with inotropes
14. If female, be pregnant or nursing (confirmed by urine test)
15. Presence of a condition or abnormality that in the opinion of the Investigators that would compromise the safety of the patient or the quality of the data
Isokinetic Performance and Function After Total Hip Arthroplasty

There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.

Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Eligibility Criteria:
Inclusion Criteria:

Patients aged 55 to 80 years unilateral primary hip osteoarthritis -

Exclusion Criteria:

bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases
Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. Injection in combination with exercise therapy might be a more sufficient therapy than injection alone. The aim of this study is to investigate a combination of steroid injection and a 10 week exercise program. In addition, the study tests the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

For many patients unspecific pain and reduced motion in the shoulder is a common complaint. It is believed that the main reason for shoulder pain comes from inflammation of the bursa.

Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. Exercise therapy for the muscles around the shoulder joint is also common treatment for shoulder pain. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. The anti-inflammatory and pain releasing effect of steroid injection in combination with exercise therapy increasing the strength and control of the muscles around the shoulder joint, might be a more sufficient therapy than injection alone. Thus, the aim of this study is to investigate a combination of steroid injection and a 10 week exercise program in patients with a painful shoulder.

Many different clinical tests are used to examine the pathological compression of the bursa during motion in the shoulder joint (impingement). However, it is actually not known if the pain in motion is caused by compression of the bursa. Part of this study therefore is to test the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

Studies comparing injection given guided by ultrasound to blind injections have shown that the ultrasound guided injections are more likely to place the active stuff correctly in the swollen bursa. In this study all injections will be given ultrasound guided. In the ultrasound examination the thickness of the bursa will be measured in all patients in order to investigate if swollenness of the bursa can explained the pain and dysfunction of the shoulder joint

Eligibility Criteria:
Inclusion Criteria:

* Pain and reduced motion in the shoulder for more than four weeks
* Ultrasound verified swollenness of the bursa.

Exclusion Criteria:

* Bilateral pain in the shoulder joints
* Rupture of the rotator cuff or biceps tendons
* Generalised disease which can explain the shoulder pain
* OA in the shoulder joint
* Diabetes
* Positive compression test of the cervical spine
Paraffin Wax Bath With Joint Mobilization Technique in Post-traumatic Stiff Knee

This project will be a Randomized clinical trial conducted to check the effect of paraffin wax bath with joint mobilization technique in rehabilitation of post-traumatic stiff knee joint. Study duration will be of 8 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, will be randomly allocated in two groups, baseline assessment was done, Group A participants were given baseline treatment along with paraffin wax bath therapy and Maitland knee joint mobilization, Group B participants will be given baseline treatment along with Maitland knee joint mobilization. Assessments will done in 4th week and 8th week via, Numeric pain rating scale, goniometer, western Ontario and McMaster universities osteoarthritis index,4 sessions per week will given, data will analyzed by using SPSS version 25.

Knee stiffness is common problem post traumatically due to process of inhibition often occurs in the early post-injury phase. This leads to the initiation of muscle atrophy within hours of the cessation of normal voluntary muscle activation further; this can result in an increase in the viscosity of synovial fluid within the joint, which provides more resistance to motion. Maitland mobilization aims to reestablish the spinning, gliding and rolling motions of the two joints. Although paraffin bath therapy has various effects such as analgesia, reducing chronic inflammation, and increasing connective tissue elasticity, it is non-invasive and has few side effects. Paraffin wax therapy, combined with exercises and the use of splints, has also been found helpful in restoring the range of movement. The current study is to explore the effect of parrafin wax bath therapy in rehabilitation of posttrumatic stiff knee range of motion, pain and functional status, and emphasize the importance of parrafin wax bath therapy adjunct with mobilization technique in treatment of knee stiffness

Eligibility Criteria:
Inclusion Criteria:

* Age 22-40 yrs.
* Both Male and female
* Fracture of unilateral knee joint.
* Subject with 3-6 month after injury
* Subjects with post traumatic stiffness of knee joint having a minimum of 70º knee flexion

Exclusion Criteria:

* Recent injuries on knee or on adjacent areas.
* Neurological problems
* Subject having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease, leg-length discrepancy of more than one-half inch
* Any non-traumatic cause of fractures
* Non traumatic cause of knee stiffness
* Malignancy
Brain Fuel - Morning Nutrition and Cognitive Function

This study will help us learn more about how what a child eats can affect how their brain works.

Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.

Eligibility Criteria:
Inclusion Criteria:

* 9-10 yr, 3rd to 5th grade
* Obese
* Right hand dominance
* Report eating breakfast at least 4 days/week
* Able to hear at least 20dB stimulus
* Visual acuity must be at least 20/40
* Biological mother available to attend visit

Exclusion Criteria:

* Full scale IQ \<80
* Children taking medications or having chronic illness/disorders
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Local Pilocarpine for Relieving Dry Mouth

The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 70 years of age
* Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.

Exclusion Criteria:

* Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
* Inability to fill out the questionnaires due to other reasons
* Prior radiation therapy of the head-and-neck region
* Known m. Sjögren disease
* Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
Ultrasound and Motivational Enhancement for Prenatal Smoking Cessation

The primary purpose of this randomized clinical trial is to test the efficacy of motivational enhancement (ME) therapy combined with biologic feedback (fetal ultrasound) for increasing smoking quit rates among low-income pregnant women considered resistant smokers. We hypothesize that ME along with biofeedback will increase the rate of validated smoking cessation at 8 months gestation by at least 10 percentage points above that produced by "Best Practice" (BP) counseling alone. This study will also examine reduction of smoking among non-quitters and maintenance of smoking cessation through 6 weeks postpartum among women who quit.

Prenatal smoking is the leading preventable cause of low birth weight in the US. Reduction in smoking during pregnancy could result in significant improvements in pregnancy outcomes and reducing the cost of health care. There is evidence that low-intensity pregnancy smoking cessation programs may be inadequate for women who are more addicted, and at educational and economic disadvantage. Motivational enhancement strategies have shown considerable promise in the treatment of addictive behaviors. Physiological feedback highlighting prenatal effects of smoking and benefits of cessation has been found to enhance prenatal smoking cessation counseling. An intervention that combines motivational enhancement counseling and physiological feedback may have powerful effects beyond low-intensity interventions or usual counseling.

Targeting women who deliver at one of the two UT-Houston teaching hospitals, Lyndon B. Johnson (LBJ) and Hermann Hospitals, pregnant women between 18 and 28 weeks gestation will be recruited from University of Texas/Harris County Hospital District-affiliated clinics, including Acres Homes, Aldine, Settegast, Baytown, and Squatty Lyons, LBJ and Hermann Hospital outpatient clinics, private practice OB/GYN's with patients who will deliver at Hermann Hospital, and area WIC (Women, Infants and Children) Program sites. Participants will be randomized to one of three groups, including 1) best practice (BP) counseling, 2) BP plus ultrasound, and 3) BP plus ultrasound plus motivational enhancement (ME) counseling. Counseling and cotinine testing will be performed at the University Clinical Research Center (UCRC) initially, at 34 weeks, and at 6 weeks postpartum. The primary outcome is the rate of smoking cessation among the women at 34 weeks gestation. Based on previous reports, projected quit rates for the 3 interventions, BP, BP + ultrasound, and BP + ultrasound + ME are .06, .12, and .20, respectively. A sample size of 360 will be necessary in order to observe these differences in quit rates. The chi-square test for trend in proportions will be used to determine statistical significance for this primary outcome.

Eligibility Criteria:
Inclusion Criteria: Pregnant women who are smokers, 16 years and older, 15-28 weeks gestation
Risk Factors for Predictors of In-hospital Death in Acute Fulminant Myocarditis

The investigators performed a retrospective, single-center observational study, and the participants with acute fulminant myocarditis were included.Then, the investigator analyzed the risk factors of in-hospital death in these participants with acute fulminant myocarditis.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of acute fulminant myocarditis

Exclusion Criteria:

chronic renal dysfunction refuse medical treatments
Effect of Mental Stress on Platelet Function

The aim of the project is to study the acute and chronic effect of mental stress on platelet adhesion and aggregation in two population composed of normal subjects at different ages

Psychological stress is an important cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could be one of the mechanisms linking psychological stress and cardiovascular diseases.

We plan to include 32 healthy subjects. (16 in every group). One group with subjects at age 20 - 49 and the other group with subjects at age 50 - 70 years.

The aim of the study will be to assess the acute and chronic effect of a standard short mental stress (2-minute Bondet Test) on platelet function and of the level of endothelin-1, catecholamines and cortisol. We plan to evaluate if age may play a role in the effect of psychological stress on platelet function.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects between 20 - 70 years of age
* written informed consent
* no evidence of diseases

Exclusion Criteria:

* pregnancy
* oral contraceptives
* smoking
* use of aspirin or NSAIDs within the last week
* use of benzodiazepines within the last week
* Alcohol or drug abuse
* participation in another study within the last month
IVM Survey Among Reproductive Medicine Specialists

Although IVM as a laboratory technology in reproductive medicine has existed for many decades, there is a lack of well-designed studies comparing the efficiency and the patient satisfaction related to IVM as compared to standard ovarian stimulation for IVF. In view of this, and in order to identify unmet needs of fertility specialists with regard to the application of IVM, the investigator developed the idea of a worldwide web-based survey analysis of fertility specialists' insights and experiences regarding IVM.

The IVM survey will be structured as a series of open questions and multiple-choice questions. In most of the questions, a single answer will be required by participants. A small number of questions will allow multiple answers. The survey will be web-based. Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic. Clinics will be identified based on whether they have worked with IVM previously but stopped, and clinics with appropriate size to offer IVM competence. When no response is obtained from selected fertility specialists, e-mails will be sent to affiliated colleagues working at the same fertility clinic. When analyzing the survey results, care will be taken to analyse the responses per fertility clinic, as responses from different fertility specialists working in the same fertility clinic should be avoided. Results will be analysed using a method that assigns equal weight per clinic and a method that weights clinic responses based on treatment volume (number of IVF cycles).

Eligibility Criteria:
Inclusion Criteria:

* IVF clinics that have worked with IVM previously but stopped
* clinics with appropriate size to offer IVM
Case-Control Viramune (Nevirapine) Toxicogenomics Study

Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.


Eligibility Criteria:
Inclusion Criteria:

Inclusion for Case

1. Male or female patients \>=18 years of age with HIV-1 infection who experienced one or more of the following adverse reactions within the first 8 weeks of starting nevirapine therapy:

   * Grade 3 or 4 LFT elevation (ALT or AST \> 5X ULN) and any symptom consistent with clinical hepatitis (see Appendix 10.1)
   * Acute liver failure secondary to nevirapine therapy\*
   * Functional group III or IV rash
   * \*Acute liver failure is defined as serious liver injury usually requiring hospitalization that may lead to death or liver transplantation.

   Inclusion for Control
2. Male or female patients \>=18 years of age with HIV-1 infection who have been exposed to nevirapine therapy for at least 18 weeks and who do not meet any of the case inclusion criteria

Exclusion Criteria:

Exclusion for Cases

1. Patients with any hepatotoxicity or rash event which in the investigators judgement is not related to nevirapine use (ex. hepatotoxicity due to alcohol or other medicinal use or rash due to other medicinal use).
2. Patients who began abacavir or TMP-SMX (trimethoprim/sulfamethoxazole) therapy 2 weeks or less prior to or up to 8 weeks after initiating nevirapine therapy.
3. Patients with AST or ALT elevations \> 5 times the ULN (\>= Grade 3) just prior to the initiation of nevirapine therapy.

   Exclusion for Controls
4. Patients who discontinued nevirapine before completing 18 weeks of dosing with 200 mg/day for 2 weeks followed by 400 mg/day thereafter.
5. Patients who developed functional group I, IIa or IIb rash within 18 weeks of starting nevirapine therapy, or any dermatologic condition that could plausibly be attributed to nevirapine.
6. Patients with ALT or AST elevations \>2.5 X ULN (\>Grade 1) within 18 weeks of starting nevirapine therapy.
7. Any hepatobiliary adverse event that could possibly be attributed to nevirapine.
8. Patients who develop any systemic reaction attributable to nevirapine use during the first 18 weeks of nevirapine treatment such as flu-like symptoms, arthralgia, myalgia, or conjunctivitis.

   Exclusion for Cases and Controls
9. Patients who have participated in the 2NN-Long-term Follow-up study (1100.1454)
10. Patients with CD4 count 150 cells/mm3 prior to the initiation of nevirapine therapy (last available result measured 6 months prior to the initiation of nevirapine therapy).
11. Evidence of acute co-infection with viral hepatitis.
12. Patients taking prednisone, prednisolone, or immuno-modulatory medication within the first 8 weeks of nevirapine therapy.
13. Patients who are unwilling to provide blood samples for DNA testing.
14. Patients who did not sign informed consent and or authorization to release protected health information per local requirements.
15. Patients without available liv
Mindfulness in Pregnancy

This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English as primary language
* less than 36 weeks gestational age
* at least 28 weeks gestational age

Exclusion Criteria:

* Use of psychoactive medications
* Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
* History of suicide attempt or current suicidal ideations
* Uncontrolled substance abuse in the last 6 months
* Patients with hearing loss
* More than three no-shows to NST appointments