cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population

This study will investigate if the performance on the Montreal Cognitive Assessment (MoCA) is associated or predictive of the outcomes in voice, swallowing or upper airway therapy in the older laryngology treatment seeking patients. The relationship between the scores of MoCA and parameters in therapy will be analyzed. The outcomes of this study could potentially impact how investigators determine candidacy for therapy and develop patient treatment plans to meet their needs. This is a collaborative study with Emory Voice Center and the NYU Voice Center.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or older with voice/swallowing/upper airway complaints
* Multidisciplinary assessment by fellowship-trained laryngologist and voice/swallow/upper airway specialized speech-language pathologist
* Voice, Swallowing and/or Upper airway disorder diagnosis
* Candidate for voice, swallowing or upper airway therapy following interdisciplinary assessment.
* State willingness to participate in the study protocol

Exclusion Criteria:

* Under the age of 60 years old
* Previously diagnosed dementia
* Central neurological disorder
* Active psychotic disorder
* Recurrent or active major depressive disorder (PHQ-9 of 10 or greater)
* Patient not able to attempt the MoCA because of a severe hearing or visual impairment
* Patients who do not speak or understand English
* Tested with MoCA in the last month
Model-based Versus Traditional Warfarin Dosing in Children

This study compares the clinical effectiveness of a new algorithm (model-based warfarin dosing) with standard practice (doctor's own judgement and intuition) designed to determine the most appropriate anticoagulant dose of warfarin in children after congenital heart surgery.

Warfarin is widely used in children after heart surgery in order to prevent complications that may arise due to blood clots forming in unwanted places - for example in the brain causing a stroke. If too little warfarin is given, there is a risk that clots may form. If the dose is too high, bleeding will result.

Traditionally, the approach to dosing warfarin in children has been to select a starting dose according to standard guidelines and to then adjust the doses for each child by monitoring the INR (which measures how quickly blood clots). However, a person's make up as well as external factors, such as age, weight, diet and genetics can affect warfarin dosing and this makes controlling the dose and hence controlling the INR, more difficult. Recently however, a more sophisticated dosing model has been developed by researchers which takes into account some of these factors. The model is designed to help doctors select the best dose of warfarin for children by individualising prescriptions.

The aim of the proposed research is, therefore, to compare the model based warfarin dosing with the traditional approach to warfarin dosing in children who have undergone congenital heart surgery. The research will involve children who are started on warfarin for the first time and also children who are already receiving ongoing warfarin therapy.

Eligibility Criteria:
Inclusion Criteria: -Children from birth up to 18 years with congenital heart disease who have been treated or to be treated with warfarin after undergoing reconstructive heart surgery at Glenfield Hospital, Leicester, United Kingdom.

Exclusion Criteria:

1. Patients aged over 18 years who are treated as 'adults'.
2. Children who refuse assent, parents who refuse consent.
3. Any significant disease or disorder which, in the opinion of the direct care team, may either put the participant at risk because of study participation or adversely affect the participants' ability to participate in the study.
Online Social Networking for HIV Prevention

In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). We will develop the intervention content with input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month assessments of condom use and abstinence among all participants


Eligibility Criteria:
Inclusion Criteria:

* Facebook user with an existing Facebook page
* at least 16
* no older than 24
* English speaker

Exclusion Criteria:

* older than 24 or younger than 16
* non English speaker
* does not have a Facebook page
Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)

The project has the following general aims:

1. Natural course and prognosis: To prospectively follow the natural course and prognosis of the different types of PFIC, to broaden the understanding of the different very rare diseases and to allow predictions about the course of disease in different types of PFIC.
2. Efficacy: To define the course of disease in FIC patients and identify associations with different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy. The course of disease will be characterized by biochemical, clinical and surgical parameters, including liver transplantation.
3. Safety: To define the complications associated with the different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy, liver transplantation). Follow up will be as long as possible.
4. (Surrogate) biomarker response: Biochemical parameters will be longitudinally collected and associated with changes in treatments / course of disease.
5. Genotype-phenotype relationships: If patient numbers permit, to establish genotype-phenotype relationships for (non)responsiveness towards different treatments in patients with genetic mutations causing the different forms of FIC disease.


Eligibility Criteria:
Inclusion Criteria:

- Genetically confirmed cases of a PFIC type disease: FIC1 deficiency, BSEP deficiency, MDR3 deficiency, TJP2 deficiency, FXR deficiency, SLC51A deficiency, USP53 deficiency, KIF12 deficiency, ZFYE19 deficiency, MYO5B deficiency, SEMA7A deficiency, VPS33B deficiency, PSKH1 deficiency.

Exclusion Criteria:

- Cases with suspected PFIC type disease, but without genetic testing data available.
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.

The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.

This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of screening or age of consent according to local law
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Histologically or cytologically confirmed metastatic or recurrent tumor types
4. Subjects who have received prior immunotherapy may be eligible
5. Subjects must have at least one measurable lesion
6. Consent to provide archival tumor tissue and pre/on-treatment biopsies
7. Adequate organ and marrow function
8. Consent to use one highly effective method of contraception

Exclusion Criteria:

1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
2. Concurrent enrollment in another clinical study
3. Active/prior autoimmune of inflammatory disorders
4. History of immunodeficiency, solid organ transplant, or tuberculosis
5. Known allergy/hypersensitivity to drug or components
6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
7. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
Longitudinal Study on the Evolution Trend and Influencing Factors of Postoperative Reflux of Esophageal Cancer Based on PEPTEST Technique

The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux

The main question it aims to answer are:

to provide evidence for high-risk groups, improvement of surgical methods for esophageal cancer, and development of health education programs to prevent postoperative reflux.

Using convenient sampling method, patients undergoing esophagectomy in thoracic surgery Department of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 were continuously enrolled. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery.

The incidence of pathological reflux at 5 time points before and after surgery was observed and compared (that is, both T-line and C-line were shown). The trend of pepsin content in saliva before and after operation; The relationship between pathological reflux and surgical factors; The relationship between pathological reflux and life habits after operation; Relationship between pathological regurgitation and demographic characteristics.

The subjects of this study were selected from the patients who underwent esophagectomy in the Department of Thoracic Surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 to December 1, 2023, and the patients who underwent esophagectomy in the Department of thoracic surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. To describe the evolution trend of postoperative reflux in patients with esophageal cancer can be used for anticipatory sexual health education. To explore the relevant factors of reflux: to identify the inherent factors, such as gender, BMI, etc., to give preventive intervention to high-risk groups; The variable factors such as the length and width of the tube stomach can be improved.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were pathologically diagnosed with esophageal cancer and underwent esophagectomy for esophageal cancer.
2. The patient can communicate in Mandarin.
3. Those who can come to the hospital for review on time.

Exclusion Criteria:

1. People with cognitive impairment or mental illness.
2. Complicating other serious life-threatening diseases (such as leukemia or autoimmune diseases).
3. Unwilling to participate in the study.
Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection.

Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.

However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old;
* Patients hospitalized at the Manzoni Hospital in Lecco or at the San Raffaele Hospital in Milan with invasive pneumococcal infection in the period between 01/01/2015 and 31/12/2019;
* Presence of a positive culture test for S. pneumoniae on blood cultures and/or liquor;
* Patients whose discharge letter or clinical documentation relating to the infectious episode is available;
* Patients whose vaccination record can be consulted (on paper or on SIAVR) and whose vaccination history is available before and after hospitalization.

Exclusion Criteria:

* Patients with positive urinary antigen for S. pneumoniae as the only microbiological finding;
* Patients whose vaccination history or vaccination records are not available.
What Should be the Anesthesia Method in Endobronchial Coil Treatment

This prospective, randomize study was conducted in a university hospital. Bronchoscopic lung volume reduction (BLVR) coil treatment has recently been introduced into clinical practice as an alternative for patients chronic obstructive pulmonary disease (COPD) with severe refractory heterorogenous emphysema to conventional medical treatment. Thirty two patients diagnosed with (COPD) with severe refractory heterorogenous emphysema undergoing BLVR coil treatment were included in the study. Seventeen procedure were performed under general anesthesia and fifteen procedure were performed under deep sedation-analgesia. in the general anesthesia group peak pressure, air leakage and end-tidal carbon dioxide were recorded. In the both groups pulse oximeter, transcutaneous carbondioxide, recovery time, bronchospasm, laryngospasm, pneumothorax, massive bleeding were recorded.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with COPD with undergoing BLVR coil treatment.

Exclusion Criteria:

* patients who refuse to participate in the study
Effectiveness of AIDS Antibody Screening

To determine the effectiveness of efforts to eliminate the human immunodeficiency virus (HIV) from whole blood and blood components in the blood supply.

BACKGROUND:

In 1986, despite programs to have persons with known risk factors for exposure to the AIDS virus exclude themselves from the blood donating population and the universal testing of all donated whole blood and blood components for the antibody to HIV, the public was fearful of acquiring AIDS via transfusion and media stories increased that fear. A major concern among members of the blood banking community was the extent to which donors infected with HIV were not identified by enzyme-linked immunoassay (EIA) systems. Most experts believed that self-deferral and the assays for the HIV antibody were eliminating the vast majority of positive units of donated blood and blood components. If all units containing HIV were being eliminated by the combined effects of self-deferral and antibody screening (and treatment of factor VIII concentrates), no recipients of only screened whole blood or blood components or factor VIII would become HIV virus and antibody positive as the result of transfusion. Alternately, if some HIV positive units of whole blood or blood components or factor VIII concentrates were not being eliminated by self-deferral and antibody screening (and treatment of factor VIII concentrates), and these units were transfused, then some transfusion recipients would become HIV antibody positive and viremic.

The initiative was part of a special Fiscal Year 1986 National Heart, Lung, and Blood Institute AIDS Plan. The concept was reviewed and approved by the National Heart, Lung, and Blood Advisory Council in February 1986. The Request for Proposals was released in May 1986. Two contracts were awarded in September 1986.

DESIGN NARRATIVE:

University of California at San Francisco: A risk assessment was made of HIV infection through prospective testing for seroconversion in women recipients of anti-HIV negative blood transfusions at the University of California San Francisco hospitals. Blood specimens were collected from each of the recipients pre-transfusion, and at two, four, and six months post-transfusion. Patients were selected based on female sex and exclusion of high risk behavior or blood transfusion during the preceding six months.

Johns Hopkins University: The rate of seroconversion was determined in a cohort of cardiac surgery patients receiving multiple transfusions of blood products screened for HIV antibody. The study was conducted at the Johns Hopkins Hospital, the Texas Heart Institute, and the Methodist Hospital in Houston. A serum sample for each patient was collected before surgery and a second sample was collected at least six months after surgery.

Eligibility Criteria:
No eligibility criteria
Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study

Plasma free fatty acids (FFAs) are thought to play a role in the generation of organ dysfunction. The investigators hypothesize that plasma FFA levels are a marker of poor prognosis in patients with sepsis. The present study will examine the relation between plasma FFA levels and severity of illness in patients with sepsis presenting to the Emergency Department. It will also examine the relation between plasma FFA levels and the risk of developing late morbidity, multiple organ dysfunction syndrome (MODS) and/or mortality during initial hospitalization and over a 30-day follow-up period.

The long term objective of this study is to investigate the mechanism by which plasma free fatty acids (FFAs) contribute to the progression of sepsis severity in infectious patients presenting to the Emergency Department. In the present study, pilot data will be generated to validate our hypothesis that elevated free fatty acids are related to outcome in sepsis.

We will examine our hypotheses with the following specific aims:

1. To determine if plasma FFA levels are related to severity of illness in patients with sepsis presenting to the Emergency Department.
2. To study the prognostic value of plasma FFA levels at predicting future morbidity and mortality in patients with sepsis presenting to the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to provide informed consent (or has surrogate present that can do so)
* Presenting to the Emergency Department (ED) for evaluation
* Clinical suspicion of infection, as indicated by the ED physician's ordering a blood culture or a current temperature of ≥38C.

Exclusion Criteria:

* Liver disease
* Hepatitis
* Alcohol consumption \>2 drinks/day for longer than 6 months
* Pregnant women
* Prisoners or other institutionalized individuals
* Unable to speak the English language
* Unwilling or unlikely to be reachable by telephone for the 30-day follow-up status assessment call
Subcutaneous Drains And Cesarean Section

A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section.

Cesarean section (CS) is one of the most common operative procedures performed in modern obstetrics. Despite being that, common, surgical techniques and steps do widely vary. These variations depend on many factors including surgeons preferences, patient s characteristics and available facilities and circumstances .

The most common complications of Cesarean section are superficial surgical site complications including sepsis, seroma formation and breakdown.

One of the common, yet debatable, practices in Cesarean section is to use a subcutaneous drain for the wound .The advantage of such a practice is to drain any blood or serous fluid that may accumulate in the subcutaneous space, which cause post-operative pain or provide a good medium for microbial growth and infection.

Thus, it is assumed that drains can reduce the burden of surgical site infection. Some surgeons, however, have raised much argument about the value of subcutaneous drains and emerging evidence raised concerns about its effectiveness. Despite this, it is evident that it is still widely used in the clinical practice.

Most randomized controlled trials on this issue, from which we draw the current evidence, were conducted in the developed countries, mainly the United States, with readily available facilities and optimum level of care. This fact raises concerns about how this evidence can be applicable in developing countries with weak health care systems and low level of awareness. In addition, Cesarean section rates are greatly higher in developing countries due to its abuse, which emphasize how the current evidence can't be applicable and in need for further updates .

The current gap between the current practice and lack of evidence has to be filled. In this study, investigators aim at providing answers for this critical issue, thus investigators can ensure women's health and provide the best quality of care following Cesarean section.

Eligibility Criteria:
Inclusion Criteria:

1. All females with previous cesarean sections admitted to Obstetrics and Gynecology Department at Menoufia University Hospitals either for elective or urgent cesarean section will be considered eligible.

Exclusion Criteria: In order to control any confounding variables, we will exclude women with an added risk of wound complications. Those will include:

1. Diabetic women (as determined by fasting blood sugar and 2-hour Post prandial blood glucose).
2. Morbid obese women (those with body mass index more than 35).
3. Smokers and alcoholics.
4. Immunocompromised women: AIDS patients and those receiving immunosuppressant agents.