cyrilzakka/clinical-trials huggingface dataset:
Coronary Disease Morbidity and Mortality in a Population

To study the entire population of Olmsted County, Minnesota, including all age categories, to examine the secular trends in coronary heart disease (CHD) mortality, myocardial infarction (MI) incidence, and natural history, including MI severity, case fatality and post-MI morbidity. Also, to examine the time trends in the prevalence of CHD at post-mortem because of the uniquely high autopsy rate in Olmsted County.

BACKGROUND:

Cardiovascular disease remains the leading cause of death in the U.S. Despite an encouraging decline in age-adjusted coronary heart disease (CHD) mortality, prevalent CHD continues to represent a major health burden, particularly in the elderly population. Most community surveillance programs, however, cannot fully characterize this problem because they are restricted to an upper age limit of 74 years and thus do not include the events occurring in an increasingly growing part of the population. Observational studies have questioned the existence of a change over time in the prevalence of anatomic coronary disease either at post-mortem examination or at coronary angiography. This remains to be further examined in a population-based setting. In addition, the natural history of myocardial infarction (MI) in the reperfusion area is unknown; in particular, there are no population-based data on the incidence of post-MI heart failure.

DESIGN NARRATIVE:

The records of all Olmsted County residents with a hospital discharge diagnosis of MI between 1979 and 1999 were reviewed, and standard epidemiologic MI validation criteria were applied; post-MI outcome over time was determined, including post-MI heart failure, angina, 30 day case fatality and long-term survival. In parallel with the analysis of time trends in CHD mortality, the autopsy reports were reviewed to examine whether the prevalence of coronary disease at autopsy has changed over time. These studies provided an assessment of the clinical and anatomical manifestations of CHD, including the outcome of acute MI, over a time period characterized by intensified primary prevention efforts and major changes in the treatment of acute CHD.

The study was renewed in July 2002 to continue surveillance of acute coronary heart disease events in order to address issues surrounding the diagnostic precision and risk stratification potential of troponin and high sensitivity C reactive protein (CRP) and to monitor secular trends in severity and treatment modalities. Novel approaches to the procurement of carefully timed blood samples allow direct measurement of the increase in number of cases of myocardial infarction using the new biomarker, troponin. An examination will be made of the prognostic value of quantitative peak troponin measured at 24 to 36 hours and high sensitivity C reactive protein measured early after symptom onset in the myocardial infarction cohort.

Eligibility Criteria:
All residents of Olmsted County, MN who are hospitalized and have an elevated Troponin level.
Postoperative Pain Associated With Three Endodontic Rotary Systems

Assessment of postoperative pain after root canal treatment using different rotary systems.

Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

* Systematically healthy patients,
* maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.

Exclusion Criteria:

* Non-vital teeth,
* teeth with apical periodontitis,
* teeth requiring endodontic retreatment,
* root resorption,
* immature / open apex,
* root canals with radiographic evidence of calcification,
* presence of more than one symptomatic tooth in the same quadrant,
* pregnancy,
* medically compromised patients,
* patients receiving medication for chronic pain,
* patients who have taken analgesics in the last 12 hours before treatment.
* teeth that have initial apical size more than 20,
* teeth that could not be treated in a single session,
* if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.
Telephone Intervention After Traumatic Brain Injury

This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI).

Subjects are recruited from the three participating TBI Model Systems of Care at Seattle, Philadelphia, and Jackson. After informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. After this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling.

The telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. The research coordinator will work with the subject on problem-solving and self-management skills. In addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak.

An outcome assessment is done by telephone at 12 months and 24 months after injury.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation
* age 16 years or older
* arrival to an emergency department within 24 hours of acute injury
* receipt of both acute hospital care and inpatient rehabilitation within our facilities
* a permanent home address

Exclusion Criteria:

* previous hospitalization for TBI
* acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder)
* progressive neurological disease
* lack of a permanent home address
* discharge to a skilled nursing facility
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

For reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam

Propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. We intend to provide sedation with propofol, 0.5 mg/Kg, and analgesia with remifentanil 0.5 microgram/Kg for reduction of dislocated shoulders. This will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/Kg, and morphine incrementally up to 0.15 mg/Kg. The primary outcome measure is time to full recovery. Secondary aspects are pain or discomfort during the procedure and operating conditions.

Eligibility Criteria:
Inclusion Criteria:

- Anterior dislocation of the shoulder suitable for manual reduction

Exclusion Criteria:

* significant other illness
* body weight 25% greater than expected
* fear of oxygen masks
* alcohol intoxication
Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. The second objective is to analyze the relationship between CA impairment and neurological outcome.

Patients : All children treated by ECMO in the PICU of the Universitary hospital of Nantes, France and of IRCCS Giannina Gaslini Institute, Genoa, Italy

Measurements: A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx \> 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years treated by ECMO

Exclusion Criteria:

* Lack of parental consent
Neuron-specific Humoral and Cellular Immune Correlates of Structural and Functional Brain Connectomics in Neuropsychiatric Lupus

Systemic lupus erythematosus (SLE) is the prototype systemic autoimmune disease. Neuropsychiatric SLE (NPSLE) is a major cause of morbidity. Its pathophysiology remains unclear and target autoantigens have not yet been identified. Site- specific autoantigen expression might correlate with imaging abnormalities. Based on existing expertise on the use of peptide/protein arrays and on antigen-specific T cell tracking, we plan to identify new fingerprints and targets for NPSLE. SLE patients +/- NPSLE and healthy subjects will undergo advanced magnetic resonance imaging. Three-dimensional data on structural or functional brain architecture will be integrated with brain transcriptome atlases and candidate antigens for autoreactive autoantibodies and T lymphocytes identified and validated. The evidence will add to current knowledge on NPSLE pathophysiology, provide new multimodal diagnostic tools for better patient care and a platform for innovative, personalized treatments.


Eligibility Criteria:
Inclusion Criteria:

Patients with SLE

* Diagnosis of SLE according to the ACR 1997, SLICC 2012 or EULAR/ACR 2019 criteria
* age ≥ 18 years (reference centre)
* age 15-17 years (affiliated centre)

Healthy subjects

* Charlson's Comorbidity Index=0 and no chronic treatment
* age ≥ 18 years (reference centre)
* age 15-17 years (affiliated centre)

Exclusion Criteria:

* History of T-cell neoplasia
* Active B-cell neoplasia or history of B-cell neoplasia of less than five years
* Contraindications to MRI
* Pregnancy
* Ongoing or past treatment with T-depleting agents
* History of brain cancer
* History of congenital brain disorders
* Cerebral disorders secondary to trauma, toxins or other metabolic or environmental factors unrelated to SLE according to the Investigator's evaluation
* Any other condition conferring excessive physical and psychological risk to the subject according to the Investigator's opinion
Identifying Learning Strategies to Improve Blood Pressure Measurement in Physical Therapy Education Programs

The purpose of this study is to determine an effective teaching strategy for Physical Therapy students in a Doctor of Physical Therapy (DPT) program that will produce consistent and accurate measuring of patient BP readings in the healthcare clinic according to the guidelines established by the AHA.


Eligibility Criteria:
This study is anticipated to have 40-45 students as participants that can vary in age range, but will mostly be centered around the 21-30 year old age range demographically. Doctor of Physical Therapy (DPT) students that are enrolled in the DPT program at Youngstown State will be recruited for this study, along with, patients who receive Physical Therapy services at the Midlothian Free Clinic. The participants will also come from both gender groups, with no exclusion criteria based on age and gender for this study.

Exclusion Criteria:

Group 1 Exclusion criteria (Experimental group):

1. Must be admitted to DPT program at Youngstown State University
2. Complete the Blood Pressure (BP) measure training module in the Clinical Skills Foundation
3. Pass the competency lab examination in Clinical Skills Foundation (\> 80% score)

Group 2 Exclusion criteria (Control group):

1. Must be admitted to DPT program at Youngstown State University
2. Have not completed the BP training module (AMA) and competency lab examination in the Clinical Skills Foundation course

Patient Exclusion criteria:

1. Must be able to follow basic commands
2. Must be able to perform a transfer to multiple surfaces
Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may improve the diagnostic yield during biopsies of pancreatic lesions

Pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential. Endoscopic ultrasonography (EUS) is highly accurate regarding the detection of pancreatic cancer, and EUS guided fine-needle aspiration biopsy (EUS-FNA) may be used to verify the diagnosis in patients with non-resectable or metastatic disease. However, EUS-FNA is only diagnostic in approximately 70% of the cases, and the reported number of "atypical", "suspicious" and "insufficient" biopsies varies.

SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic tissue fractions ("trucut biopsies") instead of single cells or cluster of cells. Preliminary data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically feasible without increasing the number of complications.

This prospective study evaluates the clinical outcome and potential complications following EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge SharkCore needle.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic lesion suspected of malignancy and EUS biopsy indicated

Exclusion Criteria:

* Resectable pancreatic lesions
Development of Pharmacokinetics Model in Pregnancy Women and Fetus

Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus


Eligibility Criteria:
Inclusion Criteria:

* 20 \<= age \< 50
* pregnant women who were administered intramuscular dexamethasone (ex) preterm labor)
* pregnant women who were administered PO clarithromycin (ex) PPROM/intrauterine infection or inflammation)

Exclusion Criteria:

* who deny the study entrance
* who administered study drug before transfer to tertiary hospital
Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke

The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic stroke patients
* Medical research council scale \>= 2 of finger or wrist flexor/extensor
* Medical research council scale \>= 2 of elbow pronation/supination

Exclusion Criteria:

* Bilateral weakness of upper extremities
* Uncontrolled medical or surgical illness
* Predisposing psychological or neurological disorders
* Severe aphasia unable to communicate
* Severe cognitive impairment not to cooperate
* Severe pain impeding upper extremity rehabilitation
Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients

This study is to detect the infertile couple (women) Anti-Mullerian Hormone (AMH) profile in major subgroups such as Poly Cystic Ovarian Syndrome (PCOS), Endometriosis, etc via age intervals and ethnic difference.

To consecutively enroll infertile couple (women) who are undergoing their first controlled ovarian stimulation cycles.

To mainly compare the inter-ethnic difference in age-specific AMH profile in unexplained infertility, male factor infertility, PCOS, Endometriosis etc. subgroups.

To detect the influence of past or present smoking on age-specific AMH levels To study the influence of body mass index (BMI) on age specific AMH levels

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as infertile couple
* Naive patients who plan to enter their first ovarian stimulation cycles
* Women among 20-43 years old

Exclusion Criteria:

* Systematic disease that impact AMH (eg. systemic lupus erythematosus (SLE), Crohn's disease etc.)
* Chemotherapy history
* Alcohol abuse
* Currently taking oral contraceptive pills
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.


Eligibility Criteria:
Inclusion Criteria:

* lipodystrophies with necessity of fat grafting
* accept to participate of the study

Exclusion Criteria:

* HIV infection
* Metastatic malignancy
* Body mass index \< 20 kg/m²
* Other severe systemic disease
A Study to Learn About the Dangers Linked to Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal Bow Sai Klib)

The purpose of this study is to explore risk factors for grade 4 neutropenia in users of the study medicine Palbociclib for the potential treatment of Palbociclib.

This study is seeking participants:

* treated with the study medicine Palbociclib
* having any breast cancer records in same month as the initiation date
* having prescription records of palbociclib from 15 December 2017 to 29 February 2024

The study design is a nested case control study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan. This design was selected since the primary objective is to explore risk factors of Grade 4 neutropenia in users of the study medicine Palbociclib.

One of the important side effects of taking Palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell).

In this study the effect of Palbociclib in decreasing the neutrophil count was studied after it was released to the market.

To do that, the study gathered details of breast cancer patients newly treated with Palbociclib from 23 hospitals and 10 medical institutes across Japan.

The below patient details were collected:

* dose of Palbociclib
* other medicines prescribed for cancer
* age
* gender
* past information on cancer treatments
* laboratory findings at baseline

The result was based on the neutrophil count collected from the laboratory data.

Around 1300 patients newly treated with Palbociclib for breast cancer was calculated by the medical information database network (MID-NET) in 6 years from 15 December 2017.

Patients who develop grade 4 neutropenia after palbociclib initiation will be matched to controls who do not develop grade 4 neutropenia. A statistical model will be used to explore risk factors of grade 4 neutropenia adjusted for important potential confounding factors.


Eligibility Criteria:
Inclusion Criteria:

* Having prescription records of palbociclib from 15 December 2017 to 29 February 2024.
* Having any breast cancer records in same month as the first prescription date.

Exclusion Criteria:

* Having an ANC less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib
* Having any records of anti-HER2 medication
Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation

Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to achieve gray-white retinal burns and duration of treatment.

As demonstrated in the Diabetic Retinopathy Study (DRS), panretinal photocoagulation (PRP) reduces the risk of severe vision loss in patients with proliferative diabetic retinopathy. The DRS recommended that PRP treatment consist of 1,200 - 1,600 laser burns 500 µm in size, one half to one burn width apart, applied to the peripheral retina in a scatter fashion. Most patients who undergo PRP experience discomfort/pain during the procedure. Once present, pain can affect the number and quality of burns delivered and can indirectly increase the number of sessions required to complete the therapy.This may in turn adversely affect patient compliance. Although retrobulbar and peribulbar blocks can provide adequate anesthesia for PRP, these anesthetic methods carry rare but serious risks such as retrobulbar hemorrhage. Previous studies have explored other ways to reduce discomfort related to PRP, including optimization of laser settings, oral and topical analgesics, subconjunctival anesthesia, and even acupuncture.

Currently, green lasers (521 - 532 nm wavelength) are most commonly utilized for performing PRP in clinical practice. Yellow lasers (577 nm wavelength) have been of recent interest in treating diabetic macular edema with micropulse subthreshold grid photocoagulation, but have not been extensively studied in PRP for diabetic retinopathy. Compared to shorter wavelength laser, yellow laser comports high transmission through dense ocular media and less light scattering than shorter wavelengths which minimizes spot size and reduces thermal spread. The limited literature comparing green and yellow laser for PRP in diabetic retinopathy has shown that yellow laser requires less power to achieve a retinal burn. In theory this should translate into a reduction in perceived pain experienced during PRP, however a comparison of green and yellow lasers in this regard has not yet been directly examined and quantified.

Eligibility Criteria:
Inclusion Criteria:

* patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina
* volunteer patients age 18 years and older.
* healthy enough to participate in the study.
* willing and able to consent to participation in the study.
* diagnosis of PDR with HRC based on clinical criteria outlined by the DRS.

Exclusion Criteria:

* patient less than 18 years of age
* institutionalized patient
* prisoner
* significant media opacity obscuring a view of the superior retina
* history of intra-ocular surgery except cataract surgery
* history of PRP laser within the last 30 days
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.

Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.

Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.

Subjects will be between 18 and 89 years of age.

In total, subject participation will last approximately 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with rotator cuff symptoms for at least 4 weeks
2. Examination reveals diffuse pain with provocative maneuvers
3. Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
4. Willingness to participate in an investigational technique
5. Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)

Exclusion Criteria:

1. Previous rotator cuff repair
2. Complete rotator cuff tear or two tendon tears
3. Pt w/ complex regional pain syndrome
4. Cervical neuropathy or other nerve pathology
5. RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
6. Evidence of intraarticular arthritis
7. Work related or compensable injury
8. Previous treatment: corticosteroid injection in the last 6 months
9. Patients who are currently pregnant