cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Trial of Academic Hospitalists

Care of hospitalized patients by "hospitalists" -- often defined as physicians who dedicate at least 25% of their practice to inpatient care -- is a recent, growing, and controversial trend in health care delivery in the United States. But despite the growth of interest in hospitalists, there have been few scientific evaluations of the concept. The comprehensive aim of this research study is to measure and analyze the effects of hospitalists on patient outcomes, costs and medical education on the general medical services of a group of academic centers.

In 2001, a study titled, "A Multi-Center Trial of Academic Hospitalists" began at the University of Chicago Hospital along with five additional academic institutions. The study is currently and successfully collecting data solely at the University of Chicago Medical Center.

The comprehensive aim of this proposed research is to measure and analyze the effects of hospitalists on patient outcomes, costs, and medical education on the general medicine services at the University of Chicago Medical Center (UC). The comprehensive aim of this research will be pursued through five specific aims:

Specific Aim #1- To assess whether hospitalists affect the cost and quality of inpatient care. This will be accomplished by analyzing the outcomes of 50,000 patients assigned to hospitalists or non-hospitalists using a quasi-randomized design based on day of the week of admission. Outcomes will include in-hospital and post-discharge mortality, readmission, emergency room use, and patient satisfaction.

Specific Aim #2- To assess the mechanisms by which hospitalists may effect the cost and quality of care. Understanding these mechanisms is essential if hospitalist programs are to be designed in ways that permit them to achieve their desired benefits. We will develop measures to assess the whether these possible mechanisms by which hospitalists may have their effects are related to costs and outcomes.

Specific Aim #3- To assess the effects of hospitalists on housestaff and student education and satisfaction. This will be accomplished by surveys administered to medical students and housestaff.

Specific Aim #4 - To attempt to quantify primary care providers' (PCP's) satisfaction with the frequency, promptness, manner, and content of communication with the in-hospital healthcare team, and to assess differences in PCP satisfaction with teams led by hospitalist and non-hospitalist attending physicians. We hypothesize that deficiencies in such communication may impair continuity of care with outpatient physicians during hospitalization and at the time of discharge, and may be improved when the attending physician is a hospitalist.

Specific Aim #5- To assess the quality of care for vulnerable elders for specific geriatric syndromes and diseases by modifying our current surveys and chart abstraction tools in our project with questions aimed to address these issues.

Eligibility Criteria:
Inclusion Criteria:

* General Medicine inpatients at the University of Chicago Hospital or Mercy Hospital in Chicago Illinois

Exclusion Criteria:

* Non-General Medicine inpatients
Gut Microbial Metabolism of Polyphenols and Cardiovascular Health (StratiPol) (Stratification Study)

There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. The objective of this study is to investigate the association between polyphenol microbiota metabolism and cardiovascular health.

The participants (n=250) with age range between 20 to 70 years old health overweight men and women. The participants will consume a polyphenol rich breakfast for three days (consisting on milled flaxseed, raspberry powder and soy milk). The participants will provide the investigators with urine and blood samples for polyphenol analysis. Cardiovascular measurements such as PWV, AIx, Blood Pressure and FMD will be performed at baseline and after 72h.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 20-70 years
* BMI between 18.5 and 35 kg/m2
* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
* Are able to understand the nature of the study
* Able to give signed written informed consent
* Signed informed consent form

Exclusion Criteria:

* Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
* Hypertensive, defined as 140/90mmHg or higher
* Obese participants with BMI superior or equal to 35 kg/m2
* Underweight participants defined by a BMI inferior to 18.5 kg/m2
* Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
* Abnormal heart rhythm (lower or higher than 60-100 bpm)
* Allergies to berries or other significant food allergy
* Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
* Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
* Subjects who reported participant in another study within one month before the study start
* Subjects who smoke an irregular amount of cigarettes per day
* Pregnant women or planning to become pregnant in the next 6 months
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth

In this prospective randomized, single blinded; split-mouth clinical trial the aim was to evaluate clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare this technique to ferric sulphate (FS) in pulpotomized primary teeth. Included were 65 children using a split-mouth design, (130 teeth). All teeth were then restored with prefabricated stainless steel crowns (SSC). Patients were recalled for clinical and radiographical evaluation after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Purpose:

The purpose of this study was to evaluate the clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare the effects of this technique to ferric sulphate (FS) agent in pulpotomized primary teeth.

Methods:

A sample of 65 children with bilateral deep carious mandibular primary molars who attended the pediatric dental clinics, at Jordan University of Science and Technology (JUST) were selected for this prospective randomized, single blinded; split-mouth clinical trial. The teeth were randomly divided into 2 treatment groups: in the ZOE group (n=65 teeth) hemostasis was achieved by a dry cotton pellet, then the chamber was filled with zinc oxide eugenol (ZOE) directly over the pulp on one side. In the FS group (n=65 teeth) hemostasis was achieved by a wet cotton pellet, ferric sulphate (FS) was applied on the pulp, then the chamber was filled with (ZOE) on the contralateral side. All teeth were restored with prefabricated stainless steel crowns (SSC). Patients were recalled for evaluation clinically after 1month, then clinically and radiographically after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Child has cooperative behaviour in the dental chair
* No history of spontaneous pain
* Deep caries in the tooth
* Carious exposure of a vital pulp
* A restorable tooth after completion of the pulp treatment
* Healthy periapical tissue on pre-operative periapical radiograph

Exclusion Criteria:

* Presence of tenderness to percussion and/or mobility
* Pathologic radiographic signs on pre-operative periapical radiograph including external or internal root resorption, calcification in the canal, periodontal membrane widening, periapical pathology, and furcation radiolucency.
The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation.

Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation.The trial investigates the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation. electric isolation of the pulmonary veins, from which atrial fibrillation is originating in most patients, is cornerstone of all atrial fibrillation patients.

The most common cause for AF recurrence is still incomplete isolation of the pulmonary veins, on the other hand, only 80% of paroxysmal and 60 % of persistent patients can successfully be cured from atrial fibrillation (despite of isolated pulmonary veins after multiple ablation procedures).

By now, non-procedure related predictive risk factors, resulting in recurrence of atrial fibrillation after catheter ablation, are only partially identified, such as obesity, hypertension and sleep apnea.

In the past year several genetic risk alleles were identified, which are associated with atrial fibrillation. By now the relation between genetic risk, which is determined for every patient by its specific genotype and the outcome of catheter ablation in paroxysmal and persistent atrial fibrillation has not yet been investigated.

The aim is to investigate the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
* written informed consent

Exclusion Criteria:

* patients under 18 years of age or patients not able to give informed consent
* prior left atrial ablation
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.

Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.

Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.

To date, no one has combined the data from both tools to try to advance the IVF field.

Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing IVF with PGT

Exclusion Criteria:

* patients undergoing IVF and not electing for PGT
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer

1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.
2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.
3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

1. Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)
2. Measurements

   1. Measurement of metabolic and cardiovascular parameters

      * glucose profiles : HbA1c, fasting glucose level
      * lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
      * adipocytokines : retinol binding protein(RBP)
      * 4, leptin, resistin, adiponectin
      * markers of endothelial and cardiac function : high-sensitivity C-reactive protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)
      * bone turnover markers : CTX, bone ALP
   2. Scoring of symptoms and signs of hypothyroidism (Zulewski score)

      * symptoms
      * physical signs

Eligibility Criteria:
Inclusion Criteria:

* radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
* age over 18

Exclusion Criteria:

* kidney failure, liver failure, heart failure
* infection
* inflammation
* autoimmune disease
* other chronic disease
The Effects Of I-PRF On Gingivectomy and Gingivoplasty

The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain level.

Considering the results found, I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.


Eligibility Criteria:
Inclusion Criteria:

(a) systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene.

Exclusion Criteria:

(a) patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.

Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults
* RA (Rheumatoid Arthritis) diagnosis for 6 months
* On stable dose of MTX of 8mg to 25mg per week
* Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2

Exclusion Criteria:

* Use of prednisone greater than 10mg/day
* Use of greater than one non-steroidal anti-inflammatory drug (NSAID)
* Use of biologic therapies for any cause
* Chemistry and hematology values outside protocol specified range
* Positive QuantiFERON-tuberculosis (TB) Gold Test
* Evidence of active lung disease on chest x-ray
* Major systemic infections
* Presence of significant comorbid conditions
* Known allergy to latex
* Women who are pregnant or nursing
Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments

This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.

This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years
* Subject in good health
* Skin laxity on the upper and lower face and neck
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period

Exclusion Criteria:

* Known sensitivity to ibuprofen, acetaminophen, or opiates
* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat in the face and neck
* Excessive skin laxity on the face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated
Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.

The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.

Eligibility Criteria:
Inclusion Criteria:

* rotavirus gastroenteritis requiring hospitalization
* immunocompetent
* born after April 15, 2006
* greater than 2 months of age on the day of admission

Exclusion Criteria:

* rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
* an immunization record cannot be obtained through the KIDSNET database
Preoperative Visual Aids on Glaucoma Surgical Patients

This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.

A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.

Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients with age ≥18 years
* Illiterate or with ≤ 9 years of compulsory education
* Indications for filtering surgery

Exclusion Criteria:

* Mental illness
* Cognitive impairment
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.

The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has an in-stent restenosis of ≥ 60% and \< 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
2. The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.

Exclusion Criteria:

1. Unprotected left main coronary disease with ≥ 50% stenosis;
2. Patient previously treated with brachytherapy in any coronary vessel.
3. Target lesion involves bifurcation including a side branch \>2.5mm in diameter.
4. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
Single Incision Versus Conventional Laparoscopic Appendectomy

This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.


Eligibility Criteria:
Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* perforation with peritonitis
* lower abdominal scar
* contraindications to laparoscopy