cyrilzakka/clinical-trials huggingface dataset:
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months post-op
* Between 40-70 years of age
* Body weight of less than 250lbs
* TKA patients will be judged clinically successful with an American Knee Society score of greater than 90
* Must have post-op passive flexion of 100 degrees with no ligamentous laxity or pain
* Participants must be able to walk on level ground without aids and ascend/descend stairs without assistance.
* Subjects will either a ConforMIS™ TKA or a traditional TKA manufactured by any other orthopaedic company.
* Patients must be between 160cm (5'3) and 193cm (6'4) tall.

Exclusion criteria:

* Subjects not willing to sign the Informed Consent and HIPAA forms to participate in the study
* BMI \>40
* Pregnant females
* Surgical procedures conducted within the past 6 months other than TKA
* Subjects from the physician's list who do not meet study requirements
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results
An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI for Hyperthyroidism.

Low RAIU in patients with hyperthyroidism represents a common obstacle in the treatment with RAI. Therefore, a higher dose of RAI must be administered to cure hyperthyroidism in these patients. If we treat patients with thiamazole before starting RAI treatment, serum TSH will rise and result in an increase in iodine uptake by the thyroid gland. By doing so, the dose of RAI to be administered might be lowered to achieve similar therapeutic efficacy.

In the past, either calculated or fixed doses of 131I have been used to treat hyperthyroidism. The supposed advantage of a calculated dose compared to a fixed dose is the lowering of hypothyroidism frequency. However, various research papers have contradicted this statement.

Antithyroid drugs and RAI therapy have been widely used in the past, either in combination, or independent from one another. This has been done primarily in older patients, to reduce the risk of exacerbation of hyperthyroid symptoms after initiation of RAI.

The use of propylthiouracil has been shown to decrease the response rate after RAI due to radioprotective effects.

The use of methimazole and carbimazole did not have a negative effect on treatment failure, as long as the medication was discontinued various days before RAI administration. Although this statement is contested in other studies.

It is interesting to evaluate retrospective data of patients treated with RAI to evaluate prognostic factors of treatment respons and post RAI hypothyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.

Exclusion Criteria:

* Prior use of L-thyroxine
* Prior thyroid surgery
* Prior RAI treatment
* Patients with thyroiditis
Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

This study is intended to assess the efficacy of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) on reducing the severity and stopping the progression of acute insomnia and depression. We also hope to gain a deeper understanding of the sociocultural, interpersonal, and individual factors that may have a role in development of insomnia and/or engagement with treatment plans.

Insomnia is a debilitating condition that escalates the risk of a myriad of disorders and is a source of significant economic burden. Insomnia takes an immense toll on individuals' physical and mental wellbeing and treating it before it can develop into chronic insomnia can save individuals untold time and money on treatment.

This study is intended to assess the effects of one virtual pCBT-I session with a nurse coach on reducing the severity and stopping the progression of acute insomnia and depression. The benefits of pCBT-I have been demonstrated in prior studies but have yet to be tested on larger sample populations.

Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network, as well as the Medicare/Medicaid data warehouse and other community partners. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control digital sleep education and pCBT-I via telehealth coaching).

Upon completion, the proposed research will not only have validated a preventative treatment for both insomnia and depression, but we will have the tools to apply it in the most effective way possible.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with low socioeconomic position as defined by income (\<35k annual household income) or education (high school diploma or less)
* Experiencing symptoms of prodromal acute insomnia (difficulty falling asleep, difficulty staying asleep, or problems waking up too early), along with worry or distress regarding their symptoms.

Exclusion Criteria:

* Under the age of 18
* Unwilling/unable to participate
* Conditions that could interfere with pCBT-I (including bipolar and seizure disorders)
* Untreated sleep disorders besides insomnia (e.g., sleep apnea, narcolepsy)
* Untreated and severe medical or psychiatric disorders
The Validity of the Use of Imaging in Cervical Cancer Staging

The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer

Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists.

CT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed.

The sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.

Eligibility Criteria:
Inclusion Criteria:

- Women diagnosed with cervical cancer Able and willing to provide informed consent

Exclusion Criteria:

Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment

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To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.

A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.

Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged from 60 days to 89 days old at the date of recruitment;
* with informed consent signed by parent(s) or guardians;
* parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
* subjects did not receive any vaccination within 14 days;
* axillary temperature ≤37.0℃

Exclusion Criteria:

* allergic to any ingredient of vaccine or with allergy history to any vaccine;
* acute febrile disease or infectious disease;
* serious chronic diseases;
* any other factor that makes the investigator determines the subject is unsuitable for this study;
Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.

This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.

Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils \<3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).

Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.


Eligibility Criteria:
Inclusion criteria

1. Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)
2. ACQ ≥1.5 and sputum eos ≥3% at the time of randomization
3. On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone
4. Total serum IgE ≥30 IU/L and positive allergy skin prick test
5. Age between 18 and 75 years
6. Ability to provide informed consent

Exclusion criteria

1. Current smoker or ex-smokers with greater than 20 pack years
2. Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
3. Currently on Omalizumab or has previously been treated with Omalizumab
4. Currently on other biologic therapies (eg. Prolia)
5. Pregnancy or lactation
6. Post bronchodilator FEV1 less than 50% predicted
Bronchoscopic Lung Ablation of Small Thoracic Tumors: the Blastt Registry

To aggregate, integrate, and analyze data facilitating the study of MD Anderson patients with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.

A. To aggregate, integrate, and analyze data facilitating the study of MD Anderson participants with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.

B. To assess the intra-operative, peri-operative, and long-term safety outcomes of robotic assisted bronchoscopic ablation of peripheral lung tumors.

C. To evaluate different oncologic outcomes including local tumor progression (LTP) by RECIST criteria, local tumor progression free survival (LTPFS), progression free-survival (PFS), disease (cancer) specific survival (DSS), and overall survival (OS).

D. To provide a deeper understanding of the evolution of radiographic findings of bronchoscopically ablated lung tumors over time.

E. To evaluate tumor and participant-related risk factors that may be associated with safety (bleeding, pneumothorax, and local infection) and oncologic outcomes (LTPFS, PFS, DSS, and OS).

Eligibility Criteria:
Inclusion Criteria:

* MD Anderson participants (defined as those with an MD Anderson Medical Record Number) with peripheral lung tumors (primary or metastatic) that have been or will be ablated via robotic bronchoscopy.

Exclusion Criteria:

* Patient with planned bronchoscopic ablations of peripheral lung tumors that were aborted for technical reasons (ablation was not completed).
The Protective Effect of Pentoxifylline on Acute Kidney Injury

Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI.

There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

Acute kidney injury (AKI) refers to a clinical syndrome characterized by a rapid (hours to days) decrease in renal function, which is a common and important diagnostic and therapeutic challenge for clinicians. The disorder has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. AKI is independently associated with important morbidity and mortality although many efforts have been used in past years. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI.

There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thus hypothesized that PTX may have therapeutic value for AKI in human. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 20 \~ 70 y/o who had admitted for acute kidney injury (renal function decreased within 48hours which meets following criteris: GFR decreased \> 25 %, serum creatinine elevated \> 0.3 mg/dl or 50%、urine amount less than 0.5 ml/kg/hour \> 6 hours).

Exclusion Criteria:

* 1. Those who had been received regular dialysis or GFR \< 30 ml/min before test. 2. Those who with acute bleeding. 3. Those who allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline and theobromine )..
Prognostic Value of 18FDG PET/CT Textural Indices in HNSCC

Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000 new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90% of the time.

Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade especially because of a high rate (up to 40%) of loco-regional recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first 2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge in head and neck cancers.

Usual prognostic factors include the tumor size, the lymph node involvement, the presence of distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18) infection status. However, pre-treatment selection of patients with poor prognosis or who require intensified therapy remains difficult despite their careful evaluation.

HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better characterization of tumor heterogeneity could help classify patients in different risk subgroups in order to improve their therapeutic management.

Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer. Its prognostic significance has already been suggested and a selection of patients at risk of recurrence appears possible using different quantitative parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters were demonstrated to be independent prognostic factors in several studies.

Texture analysis is currently highly studied in order to characterize tumor heterogeneity, and consists in extracting texture indices from different imaging modalities such as FDG PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a tumor volume of interest and selecting several parameters such as the resampling method, matrix definitions and indices formula. Several studies conducted on small series of patients with HNSCC have showed promising results to predict survival, analyzing various cancer anatomic subsites, tumor segmentation methods and texture indices.

The objective of this study is to assess the prognostic value of texture indices in a large cohort of patients with HSNCC, including any anatomic subtype and staging.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven HSNCC
* written consent

Exclusion Criteria:

* previous head and neck malignancy
Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen.

Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery.

The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation.

After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor.

48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery.

At discharge, the patient will be given two questionnaires about pain and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 18-85 years old
* above 50 kg
* American Society of Anaesthesiologists Physical Status 1-3
* Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
* Patients with anticipated hospitalization of two nights
* Expected to require parenteral opioids for at least 48 hours for postoperative pain
* Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

* Hepatic disease, e.g. twice the normal levels of liver enzymes
* Kidney disease, e.g. twice the normal level of serum creatinine
* Epidural analgesia or regional blocks (including Transverse abdominis plane block)
* Acetaminophen sensitivity or known allergy
* Female patients who are pregnant or breastfeeding
* Patients taking warfarin
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes

This prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made prospectively by two centers of Inter -region South Mediterranean,


Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome (ST + \< 12 hours and ST- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention.

Exclusion Criteria:

* Cancer
* Chronic inflammatory disease
* Infectious disease
* Erythrocyte \<4 G/l
* Thrombopénia less than 100 000/mm3 ;