cyrilzakka/clinical-trials huggingface dataset:
Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study

The purpose of the Study is to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

The investigators previously reported the beneficial effect of early use of low-dose pravastatin on major adverse cardiac events in patients with acute myocardial infarction and mild to moderate hypercholesterolemia in the OACIS-LIPID Study. The PRACTIC study is designed as the OACIS-LIPID II trial to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

Eligibility Criteria:
Inclusion Criteria:

1. the presence of 2 of the following 3 criteria:

   1. a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
   2. typical electrocardiographic changes (i.e., ST-segment elevation of \>0.1 mV in ≥1 limb or 2 precordial leads, ST-segment depression \>0.1 mV in ≥2 leads, abnormal Q waves, or T-wave inversion in ≥2 leads)
   3. an increase in the serum creatine kinase levels to \>2 times the normal laboratory value.
2. the serum level of LDL-C is ≥70 and 130\> mg/dl in the first blood examination soon after admission

Exclusion Criteria:

1. concurrent therapy with any HMG-CoA reductase inhibitor
2. previous history of the side effects associated with any HMG-CoA reductase inhibitor
3. life-threatening arrhythmia
4. severe chronic congestive heart failure
5. hepatic dysfunction
6. renal failure
7. cerebrovascular disease
8. poor controlled diabetes
9. pregnancy, lactation
10. age \<20 years
11. disability of taking medicine or absence of a written informed consent
12. Patients whom the doctors consider inappropriate by any other reason
Comparison of the Effects of Stabilization Splint and Muscle Exercises on Muscle Thickness and Pain in Patients with Central Sensitization Caused by Myofascial Pain: a Randomized Controlled Clinical Trial

Myofascial pain is a regional muscle pain condition characterized by hard local areas and tender bands, known for the presence of trigger points in muscle tissue. The treatment is to eliminate the etiologic factor. Regular exercise is recommended to relieve the trigger points. Occlusal splints, considered the gold standard in the treatment of temporomandibular joint disorders, are used to manage and control symptoms. In this study, patients between the ages of 18-45 years who applied to Çukurova University Faculty of Dentistry, Department of Prosthodontics with the complaint of myofascial pain and scored above 40 on the central sensitization scale will be taken as a sample.

Patients scoring 40 and above on the CSI scale will be evaluated according to the Diagnostic Criteria - Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) and four groups will be formed including the control group diagnosed with myofascial pain. Bilateral masseter and temporal muscle thicknesses of all participants will be measured and recorded with a Clarius L7 ( Vancouver, Canada) ultrasound device. The control group will be trained and asked to comply with the training until the study is completed. The participants in the first experimental group will use occlusal splints that are digitally designed by transferring the impressions taken with intraoral scanner (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and printed on three-dimensional printers. Participants in the second experimental group will be given home-based exercise programs prepared by physical therapists. Participants in the third experimental group will use occlusal splints digitally designed by transferring the impressions taken with intraoral scans (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and printed on three-dimensional printers and will be given home-based exercise programs prepared by physical therapists.

Muscle thickness measurements will be repeated at week 2, week 4, week 8 of the treatments and pain report forms will be filled out. As of week 8, treatments will be terminated and patients will be called to the clinic for control visits at week 12 and muscle thickness measurements will be repeated and pain report forms will be filled.

Eligibility Criteria:
Inclusion Criteria:

* Examination of bilateral masseter and temporal muscles for the presence of trigger points
* Score above 40 on the CSI scale

Exclusion Criteria:

* Noise during jaw movements (click, crepitation)
* Presence of systemic diseases involving joints (rheumatoid arthritis)
* Having received treatment for joint discomfort in the last six months (botox, splinting, exercise, counseling)
* Use of drugs affecting the central system (gabapentin, pregabalin, tricyclic antidepressants)
Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Eligibility Criteria:
Inclusion Criteria:

* currently receiving Phase III CR at Hope Clinic
* are 18 years of age or older
* can read and communicate in English
* able to follow instructions to walk
* provided signed informed consent
* willing to wear Fitbit throughout the study
* owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
* willing to receive text messages and phone calls from the research team.

Exclusion Criteria:

* are pregnant or lactating
* have scheduled surgery or traveling within the next 8 weeks
* currently participating in other health promotion program
* sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").
Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease

assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel wall vascularity In activity and remission . peripheral hemogram in relationship to activity inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume( MPV) . also,the investigator will evaluate the outcome of different lines of treatment traditional and biologic therapy (response to treatment,times of activity and complications)

the participants will follow up the patient for 1 year in the first visit

All patients in this study will be subjected to:

1. Detailed history.
2. Careful physical examination
3. laboratory investigation

   1. complete blood picture.
   2. liver function
   3. kidney function
   4. Iron profile(serum iron ,serum ferritin
   5. ESR (erythrocyte sedimentation rate )

   g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)
4. Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)
5. Doppler us (mesenteric vessels)
6. colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment response to treatment

Eligibility Criteria:
Inclusion Criteria

* patients diagnosed ulcerative colitis at age(15-60)
* patients diagnosed crohns disease at age(15-60)k

Exclusion criteria

* liver cirrhosis and portal hypertension
* spontaneous bacterial peritonitis
* Ischemic colitis
Complications After Appendectomy in Elderly

this study evaluate postoperative complications after appendectomy


Eligibility Criteria:
Inclusion Criteria:

* elderly patients with AA

Exclusion Criteria:

* conservative treatment, psychological factors
Helping Empower Liver and Kidney Patients

The overall purpose of this study is to develop and test a web-based decision aid (DA) to support patients with Hepatitis C and Chronic Kidney Disease during decisions about whether, when, and how to treat each illness. Patients will have the opportunity to learn about their hepatitis C and kidney disease, initiate thought about what matters most to them and choose a treatment plan for their liver and kidney disease that works best for them. Investigators will evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. There are three (3) primary aims of this project: (1) to develop the DA; (2) to pilot-test the DA to determine efficacy, usability and likelihood of using it in routine practice; (3) to explore stakeholders feedback on the usefulness of the DA and likelihood of implementing the tool.

First, for Aim 1, Investigators along with direction from a diverse expert advisory group of nephrologists, hepatologists, and patient partners developed a decision aid based upon International Patient Decision Aids Standards guidelines, literature reviews, and expert advisory reviews. It includes plain language education, interactive learning modules personalized tailored information to help individuals use and consider information appropriate to their values and needs, and guidance on discussions with clinicians about treatment goals. Second, for Aim 2, Investigators will pilot-test the decision aid with 70 individuals in a pre-post within-subjects study design to evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. Lastly, for Aim 3, Investigators will conduct 30 semi-structured qualitative interviews with both clinicians and participants after the pilot evaluation of the decision aid to gather feedback about implementing the tool into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Must read and understand English AND
* Must have Hepatitis C (any genotype) and Chronic Kidney Disease (any stage)

Exclusion Criteria:

* Developed jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy also known as Decompensated cirrhosis; or
* Currently has or had liver cancer (Hepatocellular carcinoma); or
* Received a liver transplant
Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients

The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).

The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel or docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 to 70 with histologically confirmed clinically stage I-III breast cancer who will receive weekly paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) chemotherapy as part of their routine care.

Exclusion Criteria:

* diabetes mellitus
* prior history of neuropathy or symptoms of numbness or peripheral pain, or prior neurotoxic chemotherapy.
* current symptoms of numbness and neuropathic pain
* treatment for bipolar disease
* treatment or concomitant use of common medications used to treat neuropathic pain, such as amitriptyline, gabapentin, pregabalin, duloxetine, for any indication
* limited English that would preclude understanding and completion of the study questionnaires
* pregnancy
* life expectancy \<12 weeks
* participation in other research studies either concurrent with or within 30 days prior to participation in this study may be an exclusion criteria
Increasing Insulin Resistance as a Predictor of Impending Bacteremia

Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of blood glucose regulation and increased insulin resistance. In sepsis there is an extreme activation of inflammatory mediators and of counter-regulatory hormones, such as cortisol, glucagon and catecholamines, which increase hepatic gluconeogenesis on the one hand, and increase the peripheral resistance to insulin on the other hand.

Disorder in the regulation of blood glucose level causes increased mortality and morbidity among intensive care unit patients with sepsis, as well as an increase in the duration of hospitalization and its financial expenses.

There are a number of parameters used in the intensive care unit to diagnose the development of sepsis within the unit, such as an increase or decrease in body temperature, an increase in CRP level, white blood cell count, pro-calcitonin level, etc It is possible that an increase in insulin resistance can also be used as a predictor of sepsis. It should be noted that almost all patients hospitalized in the intensive care unit are treated with a continuous infusion of insulin to balance their blood glucose level, including patients who are not diagnosed with diabetes prior to their hospitalization in the unit. This is in light of the increase in insulin resistance for the reasons listed above among patients in critical condition, and also due to the need to maintain blood glucose values in the range of 140-180 mg/dl, since high blood glucose values among patients hospitalized in the intensive care unit are associated with increased morbidity and mortality.

We would therefore like to investigate whether an increase in insulin resistance, as expressed in an increase in the patient's insulin intake, can predict the development of sepsis secondary to bacteremia in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:Patients aged 18-100, diabetic and non-diabetic, admitted to the General Intensive Care Unit from January 2013 to January 2021 (inclusive) for any reason, required during their hospitalization a continuous infusion of insulin, and developed during their hospitalization acquired bacteremia after more than 48 hours from ICU admission.

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Exclusion Criteria:Patients who did not receive a continuous insulin infusion, patients with bacteremia of non-pathogenic bacteria (contamination), patients who developed bacteremia less than 48 hours after ICU admission, patients who received drugs that might influence insulin resistance (steroids, glucagon) or patients with other reasons that might explain an increase in insulin resistance other than infection.

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Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.

The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.

Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.

The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.

Eligibility Criteria:
Inclusion Criteria:

1. HIV+
2. ≥18 years old
3. Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
4. Able to speak and read English at the level to be able to complete the study procedures
5. Have telephone access.

Exclusion Criteria:

1. Cognitively impaired
Selection of Surgical Technique in Rectal Cancer

Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.

Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
* Age ≥ 18 years.
* Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
* Initial stage T1-T4a. Any N. Any M.
* Intention for R0 resection.

Exclusion Criteria:

* Colorectal tumor with histology different from adenocarcinoma.
* Synchronous colon tumor.
* Benign pathology or adenoma.
* Tis.
* T4b or oncological multivisceral resections.
* History of neoplastic colorectal surgery or local excision or TAMIS.
* Perforated or obstructive rectal neoplasm.
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests

Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with asthma or suspected CVA who have previously participated in or who have expressed interest in participating in studies will be invited to participate in the study. Previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion, but medication use will be recorded and examined in the analysis.

Exclusion Criteria:

1. An exacerbation necessitating any alteration in medication, emergency department visit or hospitalizations within the previous 4 weeks;
2. Inability to perform acceptable quality spirometry;
3. Medical contraindications to methacholine challenge testing 35, including:

   1. Severe airflow limitation (FEV1 \<50% predicted or \<1.0 L);
   2. Heart attack or stroke in last 3 months;
   3. Uncontrolled hypertension, systolic BP \> 200 or diastolic BP \> 100;
   4. Known aortic aneurysm;
   5. Moderate airflow limitation \< 60% predicted or \<1.5 L);
   6. Inability to perform acceptable quality spirometry;
   7. Current use of cholinesterase inhibitor medication (for myasthenia gravis); and
   8. Pregnant or nursing mothers.
4. Smoking history in excess of 10 pack years;
5. Medical contraindications to mannitol challenge testing, including:

   1. Aortic or cerebral aneurysm;
   2. Uncontrolled hypertension; and
   3. Myocardial infarction or a cerebral vascular accident in the previous six months).
6. Women who are pregnant or breastfeeding because the effects of a possible hyperresponsiveness reaction to mannitol in mothers and/or fetuses are unknown and many compounds are excreted in human milk therefore caution should be taken.