cyrilzakka/clinical-trials huggingface dataset:
Betadine Effect on Nasal Mucosa Cilia

The goal of the proposed study is to identify PVP-I at 1.25% as an appropriate intranasal topical preparation for patients undergoing rhinoplasty with no effect on the nasal mucosa cilia (NMC) or olfaction using the saccharin transit time (STT) test as a method for evaluating NMC function. PVP-I has been shown to be viricidal in the upper aerodigestive tract. This study is highly-relevant, as protection for individuals with a high risk of exposure to respiratory pathogens has become increasingly important in the setting of recent viral epidemics such as SARS-CoV-2. Septorhinoplasty is commonly performed throughout the world and there is a paucity of standardized testing in surgical facilities. Much of our understanding of the current COVID-19 pandemic is extrapolated from MERS and SARS data. It is our hope that this study's relevance for the current pandemic remains so in the unfortunate event of another pandemic in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients at Boston Medical Center undergoing septorhinoplasty, without inferior turbinate reduction
* Normal range baseline saccharin transit time (STT)
* SARS-CoV-2 Testing Negative at the time of the procedure o Per institution guidelines, patients scheduled for surgery undergo a preoperative nasopharyngeal test within 24 hours of their procedure - per institution protocols.

Exclusion Criteria:

* Known history of:

  * thyroid dysfunction
  * renal disease
  * autoimmune disease affecting the upper airway
  * immunocompromised
  * pregnant, breastfeeding
* Patients determined to have dysfunctional nasal mucosa cilia (NMC) function based on a STT time of ≥30 minutes
* Patients with a contraindication to Povidone-iodine (PVP-I) including history of allergy/anaphylaxis to PVP-I, labile thyroid disease, history of contact dermatitis, active radioiodine therapy, pregnancy/nursing
The Effects of a Tourniquet in Total Knee Arthroplasty.

About 5000 total knee arthroplasties (TKA) are performed annually in Norway. Pain and reduced physical function is present in patients operated with TKA up to a year after surgery and about one of five patients are not satisfied with the outcome from TKA surgery. The use of tourniquet during surgery may also have impact on pain and physical function. Whether TKA surgery should be performed with or without the use of tourniquet, is a much-debated issue in orthopedic surgery today, and there is still no consensus in this field. This study will investigate early muscle strength and power recovery, neuromuscular recordings, neuronal changes and patient reported outcome measures after surgery with tourniquet versus not tourniquet.The findings in this study are expected to have implications for rehabilitation and the outcome of the TKA surgery.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthrosis qualifying for total knee arthroplasty

Exclusion Criteria:

* Coagulation disease
* Rheumatoid arthritis
* Peripheral vascular disease
* Malign disease
* Pregnancy
* On-going infection
* Not able to understand written and oral information in Norwegian
Improving Intermediate Risk Management. MARK Study

Cardiovascular risk functions fail to identify more than 50% of patients who develop cardiovascular disease. This is especially evident in the intermediate-risk patients in which clinical management becomes difficult. The purpose of this study is to analyze if ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

Primary prevention of cardiovascular diseases is a priority in public health policy of developed and developing countries. The fundamental strategy consists in identifying people in a high risk situation in which preventive measures are effective and efficient. However, specificity and sensitivity of risk equations are modest, which means that approximately 50% of the patients who are likely to develop a vascular event and would benefit from preventive measures are not considered at high risk. While 30% of the subjects considered at risk don't really benefit from preventive measures. Moreover, decisions which imply thousands of people and can determine drug treatment indications are taken every day in primary care centers. These decisions are based mostly on the result of estimations about the probability to develop a vascular disease in 10 years. Improvement of these predictions in our country will have an immediate, clinical and welfare impact and a short term public health effect.

The purpose of this study is to analyze if ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Population aged 35 to 74 which have an intermediate cardiovascular risk.

Exclusion Criteria:

* Terminal illness or institutionalization at the appointment time
* Personal history of atherosclerotic disease
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
* Chronic HCV infection
* Subject must be HCV treatment-naïve or have failed prior HCV treatment
* Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion Criteria:

* Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
* HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
Pilot Social Network Weight Loss Intervention

Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.

Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.

Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and \<65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.

We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake

Eligibility Criteria:
Inclusion Criteria:

1. self-identification as Hispanic or Somali
2. member of an HPs social network
3. age≥18 and \<65
4. willingness to participate in all aspects of the study
5. provision of informed consent.

Exclusion Criteria:

1. pregnancy at the time of enrollment
2. serious medical conditions or disabilities that would make physical activity difficult.

   * To avoid stigmatization, a normal weight (BMI\<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.
Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer

This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.

Plan for conducting the study:

* The patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. The patient signes a consent form to participate in the study.
* Pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: Cho Ray Hospital and University of Medicine and Pharmacy Center.
* Post-operative data will be collected and based on the general procedure.

Data analysis

* To determine the incidence of pancreatic fistula and bleeding, survival analysis will be used.
* To determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p \< 0.05 will be included in the multivariable regression model to determine the real risk factors.

Sample size:

• The investigator expect approximately 100 patients in the first year in both centers. And the investigator hope at least 110 patients in the whole conducting time.

Plan for missing data:

• The investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. Investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periampullary cancer meet the following criteria:

  * Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.
  * The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)

Exclusion Criteria:

* The patient has other organ's cancer beyond periampullary cancer.
* Patient's medical conditions contraindicate for anesthesia.
* The patient does not consent to participate in the study
A Multi-omics Study of Epithelial Ovarian Cancer

This study aims to analyze the multi-omics results between epithelial ovarian cancer (EOC) patient with different FIGO stages and pathological subtypes. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the invasiveness and tumorigenesis of EOC.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary epithelial ovarian cancer
* Signed an approved informed consents
* Feasible for biopsy

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Prevention of Diabetes Progression Trial (PDPT)

The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
* ages 2 to 40 years at diagnosis
* enroll within 3 months of diagnosis
* test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling

Exclusion Criteria:

* Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
* Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
* Active significant infection
* Limited life expectancy because of disease other than diabetes
* Pregnancy
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus

VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.

This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.

Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women
* Diagnosis of T1DM for a minimum of 3 years.
* Stable, optimized diabetic regimen
* Acceptable candidate for implant and explant procedures.
* Willing and able to comply with protocol requirements.
* Meet insulin dosing requirements per protocol

Exclusion Criteria:

• Advanced complications associated with diabetes
Characterization of the Mechanisms of Resistance to Azacitidine

Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known.

The research program and clinical studies we proposed focus on two major aspects:

- Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy.

- Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* High Risk or Intermediate 2 MDS (IPSS)
* AML-MD (WHO classification)
* Treatment with minimum three to six cycles of Azacitidine
* Informed consent form signed

Exclusion Criteria:

* Treatment with others chemotherapies alone or in association
Efficacy of Kinesiology Tape on Neck Disability

Sixty participants with nonspecific neck pain were randomly assigned to either the kinesiotaping (n=30) or exercise (n=30) group.

At the beginning, at the 2nd week and at the 1st month, activity and rest pain with visual analog scale, cervical lateral flexion and rotation with goniometer, neck disability scale and trapezius thickness, trigger point volume, trigger point diameter, trigger point area (with ultrasonograpic imaging) will be evaluated.

After the initial evaluation of the patients in the kinesiotaping group, 'I' strip kinesiotape will be applied with the space correction technique for the upper trapezius muscle, for a total of 4 sessions, 2 days a week, and the patients will be included in the 1-month home exercise program. Patients will be evaluated at the start of treatment, Week 2, and Month.

Patients in the control group will only be included in the 1-month home exercise program. Patients will be evaluated at the start of treatment, Week 2, and Month 1.

The participants inclusion criteria were; age between 18 and 65 years, symptom duration of at least 3 months. The exclusion criteria were as follows: (1) a diagnosis of cervical radiculopathy or myelopathy, (2) a history of acute neck injury or cervical surgery (3) diagnosis of psychiatric disorders (4) recent trigger-point injection or participation in a physical treatment program witin the last 6 monhts (5) any allergies to the tape and (6) having already received treatment with kinesio-taping.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* symptom duration of at least 3 months

Exclusion Criteria:

* a diagnosis of cervical radiculopathy or myelopathy
* a history of acute neck injury or cervical surgery
* diagnosis of psychiatric disorders
* recent trigger-point injection or participation in a physical treatment program witin the last 6 monhts
* any allergies to the tape and
* having already received treatment with kinesio-taping.
Anatomical Observational Study of the Characteristics of the Suprascapular Notch Using Ultrasound.

Carrying out an anatomical study to describe the suprascapular notch. The project is to determine the characteristics (measured dimensions and shapes) of the suprascapular notch by ultrasound measurements on a series of healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* all adult hospital workers from the two departments concerned

Exclusion Criteria:

* refusal to participate in the study
A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology

Development and pilot testing of a cognitive self-management intervention for persons with multiple sclerosis (PwMS) emphasizing physical activity (PA) delivered via web-based video conference.

The primary objective of this study is to develop and pilot test an innovative cognitive self-management intervention for PwMS delivered via web-based video conferencing. Data derived from interviews will be used to guide the adaptation of Stuifbergen's 8-week Memory, Attention, and Problem-Solving Skills in MS (MAPSS-MS) intervention to be delivered via web-based video conferencing. The adapted MAPSS-MS intervention will be feasibility tested in small groups of PwMS. Outcome variables include: (1) neurocognitive function assessed using the NIH Toolbox®, a comprehensive set of psychometrically sound neuro-behavioral measures that quickly assesses cognitive functions using an iPad, (2) objective PA and sleep using Actigraph™ accelerometers, (3) self-reported sleep, depression, and fatigue using the Patient-Reported Outcome Measurement Information System (PROMIS), and (4) MS specific self-management using the Multiple Sclerosis Self-Management Scale (MSSM). Community-residing PwMS, age 21 to 70, will be recruited from Central Texas to participate in Phase 1 interviews (n=5) and Phase 2 pilot testing (n=20) of the adapted version of the 8-week MAPSS-MS cognitive self-management intervention emphasizing PA delivered via web-based video conferencing. In Phase 2 pilot testing (n=20), an intervention group (n=10) will be compared to an "enhanced usual care" control group (n=10).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically definite MS documented by their healthcare provider
* Age 21 to 70
* Capable of understanding and complying with the study protocol
* Able to read and write in English
* Stable disease at the time of entry into the study (relapse free for at least 90 days)
* Willing to participate in an 8-week study promoting physical activity, MS self-management and compensatory cognitive strategies, and data collection
* Have subjective concerns about their cognitive functioning (score ≥ 10 on the 20-item Perceived Deficits Questionnaire)
* Any gender
* Any ethnic/racial group

Exclusion Criteria:

* Currently pregnant or plan to be
* Diagnosed with cardiovascular or respiratory disease, other medical causes of dementia or other neurological disorders that may impact cognition or emotions
* Evidence of major psychiatric disorder
* Major functional limitations that preclude them from participating in the study
Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.

Telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (COPD) disease. Telemedicine, for monitoring disease exacerbation, is the focus area of our research. The patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of COPD exacerbation or pulmonary infection. The self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. After one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. With the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. Data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. The selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. All patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. It is expected that the monitoring of symptoms and signs will support patient empowerment.

The investigation is planned to assess the clinical and economic effects of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease COPD with FEV1/FVC (Forced Expiratory Volume in 1 second / Forced Vital Capacity) below 70% at all times during the study. FEV1 below 51% during inclusion and during the further study. Inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms.

Exclusion Criteria:

* Not able to give written or oral consent
* Terminal disease, such as cancer
* Unstable heart disease, such as coronary infarction within the last to month
* Disabling psychiatric disease
* Asthma
* Inability to use the equipment
* Severe language barriers
* Drug abuse
* Alcohol abuse