cyrilzakka/clinical-trials huggingface dataset:
New Modalities for Detection of Oropharyngeal Cancer

Background: The incidence of human papilloma virus-driven oropharyngeal cancer (HPV-OPC), a type of head and neck cancer, is rapidly increasing within the US. Currently, there are no screening methods for early detection. HPV16 E6 antibodies combined with ultrasound imaging may be a promising method for early detection of HPV-OPC. However, prior to testing HPV16 E6 antibodies and ultrasound for HPV-OPC screening, larger studies are needed to further validate the utility of these methods in the diagnostic setting among patients with suspected and/or symptomatic HPV-OPC.

Objective/Hypothesis: To investigate two promising screening modalities for the detection of HPV-OPC, transcervical ultrasound and HPV16 E6 antibodies. The investigators hypothesize that both ultrasound and HPV16 E6 antibodies will be highly sensitive for the detection of symptomatic HPV-OPC.

Specific Aims: (1) Determine the sensitivity of ultrasound to characterize OPC tumors compared to current standard imaging modalities among patients with suspected or confirmed OPC. (2) To determine the sensitivity and specificity of HPV16 E6 antibodies for HPV-OPC. (3) Determine the sensitivity of ultrasound to detect HPV-OPC compared to current standard imaging modalities among patients that present with a neck mass and unknown primary tumor.

50 patients with suspected or confirmed OPC will undergo a transcervical ultrasound during their first visit at the Vanderbilt Head and Neck Clinic in addition to other imaging modalities (CT, MRI and/or PET) as indicated as part of routine clinical care; patients will also be asked to provide a blood specimen. Ultrasound exams will be performed by a clinician blinded to details of the case. All patients will have a CT as part of their diagnostic work-up. Sensitivity of ultrasound to detect tumors identified by CT will be determined. Approximately 40% of patients are expected to test negative on CT requiring MRI and/or PET imaging. Among this subset, the sensitivity of ultrasound to detect tumors identified by either PET and/or MRI will be determined. Tumor size will be determined by 3 ultrasound measurements along the largest diameter of the tumor; agreement between ultrasound and the clinical imaging modalities will be calculated. The investigators will recruit an additional 78 OPC patients with pre-treatment serum banked within the Vanderbilt Head and Neck Cancer Biorepository (18 HPV-negative, 60 HPV-OPC) for HPV serologic analyses; total: 128 samples. Sensitivity and specificity of HPV16 E6 antibodies for detecting HPV-OPC will be calculated. As an exploratory aim, the proportion of tumors undetectable by CT, PET, and MRI, but detected by ultrasound will be determined.

Eligibility Criteria:
Inclusion Criteria:

* 21 years or older
* Suspected or confirmed oropharyngeal cancer
* Previously untreated cancer
* First cancer diagnosis

Exclusion Criteria:

* No to any of the inclusion criteria
* Under 21 years of age
* Inability to provide blood or oral rinse specimen
Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer

Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.

Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Cervical cancer, advanced or recurrent metastasis
* Measurable and assessible tumor lesions
* Used ordinary paclitaxel or platinum drugs, more than 28 days
* Aged 18-70
* KPS score\> 60 points, expected to survive more than 3 months
* Normal bone marrow function
* The function of liver and kidney had no obvious damage
* Normal function of vital organs
* No brain metastases
* Patients or their agents to sign informed consent
* Compliance, and can be followed up regularly

Exclusion Criteria:

* Brain metastases
* Serious complications
* Acute inflammatory response
* Combined with other tumor
* Pregnancy or breast-feeding women
* Vertebral metastasis with nerve compression symptoms
* Large volume of pleural effusion, pericardial effusion
* Other malignancy within five years
* Drug allergy
* Other chemotherapy contraindications
* The possibility of pregnancy, and not willing to contraception
* No measurement of lesion
* Mental illness which is difficult to control
Effect of Some Drugs on Liver Fibrosis

Effect of Some Drugs on Liver Fibrosis

The study aimed at evaluating the effect of Some Drugs on Liver Fibrosis

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C

Exclusion Criteria:

* Acute hepatitis
* Thalassemia
Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.

In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.

In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.

The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.

The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.

Eligibility Criteria:
Inclusion Criteria:

* adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia

Exclusion Criteria:

* patient refusing to participate in the study or without health insurance
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds

The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age
2. Patient with a chronic lower extremity ulcer (i.e DFU, VLU, ...)
3. Ulcer duration \>30 days.
4. Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
5. Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
6. Subject can read and understand the Informed Consent form

Exclusion Criteria:

1. Presence of active underlying osteomyelitis.
2. Known malignancy in the reference wound bed or margins of the wound
3. Cannot withdraw blood in the required amount technically.
4. Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
5. Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
6. Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study
Trial of a Tailored Message Program to Implement CHF Guidelines

Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.

Background:

Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.

Objectives:

Patients with CHF consume a significant proportion of healthcare resources, with exacerbations of CHF being the second most common reason for medical admission to VA medical centers. Therefore, the main objective is to understand the impact of a tailored education message program designed for direct use by patients on medical resource use. Other objectives include understanding the tools impact on patient compliance and quality of life.

Methods:

Patients have been randomized to one of two groups: 1) intervention group or the 2) control group. The intervention group receives the tailored education messages program. This program assesses patients� beliefs about compliance with medications, diet, and self-monitoring. Based on identified barriers to compliance, intervention patients receive a tailored educational message to dispel these beliefs and improve compliance. The control group interacts with a generic healthcare website. Patients in both groups are monitored for hospitalization; emergent care visits, compliance with prescribed treatment and quality of life

Status:

Project work is ongoing.

Eligibility Criteria:
Inclusion Criteria:

EF \<40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English.

Exclusion Criteria:
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.

Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.

Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin \[IVE\] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.

Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a \>95% reduction in prevalence sustained for nine months.

Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.

Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.

Eligibility Criteria:
Inclusion Criteria:

* Able to give consent

Exclusion Criteria:

* Unable to give consent.
* Less than 5 years of age (not eligible for ivermectin)\*\*
* Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
* Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)\*\*
* History of allergies to the drugs being studied
* Residents who cannot swallow tablets

Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations
Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-aged Children?

The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.

The purpose of this investigation is to examine the impact of portion size on intake of a low energy dense food (fruit). Preschool-aged children will be provided with a small and large portion of applesauce (low-energy-dense food) and chocolate pudding (higher-energy-dense food) and allowed to eat the foods ad libitum during an afternoon snack in their usual preschool classroom. Measures of the amount of each food (grams and kilocalories) consumed will be taken.

The following hypotheses are proposed:

1. A significant main effect of portion size will occur, such that children will consume more food, both in grams and kilocalories, in the large portion as compared to the small portion conditions.
2. A main effect of food type on caloric intake will occur, such that children will consume less calories in the applesauce condition as compared to the pudding condition, due to the differences in energy density of these foods. It is not anticipated that a difference in grams consumed from each food will occur.

Eligibility Criteria:
Inclusion Criteria:

* All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate.
* Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon.

Exclusion Criteria:

* Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study.
* Did not attend all feeding sessions.
* Did not consume more than 5 grams from any of the foods on an occasion.
Prevalence of Female Circumcision Among Young Women in Beni-Suef, Egypt

Female circumcision (FC) is a deeply-rooted practice in Egypt with deblitating physical and psychological consequences, however the previous two decades witnessed sincere efforts to counterfight this practice. The objective of this study is to investigate the prevalence of circumcision among young women (12-25 years) in Beni-Suef , Egypt.

This cross-sectional study was conducted on a total of 3353young women residing urban and rural quraters in Beni-Suef City. Data was collected usinga questionnaire that included information about the socio-demographic charcteristics of the women, their gynecological data, exposure to FC, and complaints associated with menses during the previous year.

Eligibility Criteria:
Inclusion Criteria:

* Young women aged 12 to 25 years living in Beni-Suef city of Egypt. the urban Metropolitan of Beni-Suef City was classified according to the socioeconomic level of its quarters to low, middle, and high levels. Out of each level, one quarter was selected randomly, by a card withdrawal, where households residing these quarters were chosen using a random start. For the rural villages surrounding the urban Metropolitan, three villages were selected randomly; one on the road to the North, one on the road to the West, and the last one on the road tothe South. Each village was clustered roughly into two sites; one to the East of the water channel and one to the West of the same water channel

Exclusion Criteria:

* Women from other places in Egypt.
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)

The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate (MTX).

Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a double-blind set-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
* Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
* Duration of RA more than 12 month
* History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
* MTX treatment at least 6 month with a stable dose at least 15mg MTX
* Patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline
* Written Informed Consent

Exclusion Criteria:

* Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
* Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
* treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
* Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at \> 18 years of age
2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography
3. Subject is willing and able to provide informed written consent
4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment
5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention

Exclusion Criteria:

1. Subject is pregnant or suspected to be pregnant
2. Subject is unable to provide informed consent
3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System

It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA) after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose® ProGlide Suture-Mediated Closure System during 1 month observation.

Prospective, Single blind, randomized

Comparative study using the Fastseal® Bioabsorbable Vascular Access Closure System as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.

After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period.There are about 6 times evaluations Including screening.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 years old and 85 years old, randomized
* Patient who submitted a written informed consent for the this trial
* The subjects should be scheduled to have an angiography or intervention through the common femoral artery (CFA).
* The subjects must be used a 6Fr sheath of the Terumo's RadiFocus Introducer II.

Exclusion Criteria:

* In case of the subject has a functure site in both legs.
* The patient who had the closing device insertion or manual compression at the targeted femoral artery within 30 days
* Patients with severe bleeding disorders (Severe bleeding history, blood coagulation disorder, thrombocytopenia (under 100,000 of platelet count), hemophilia, anemia (Hgb\<10g/dL, Hct\<30%), Thrombasthenia, any related bleeding disorder
* Hypertension patient BP ≥180/110mmHg
* In case of thrombolysis(ex: streptokinase, urokinase, t-PA) within 24hr
* If there is any hematoma, arteriovenous fistula(AVF), false aneurysm existed at the access site of femoral artery
* Severe obesity BMI \> 40kg/m2
* In case of prior stent placement or artificial vessel insertion in the common femoral artery(CFA)
* Under 5mm of Common femoral artery (CFA) diameter
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke

Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke


Eligibility Criteria:
Inclusion Criteria:

* Stroke with cerebellar hemorrhage or infarction
* ataxia or tremor on upper extremities secondary to stroke
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* History of surgery of affected upper limb
* Fracture of affected upper limb