cyrilzakka/clinical-trials huggingface dataset:
Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling

The primary objective is to use "network targeted sampling design" to detect active and/or undiagnosed cases of COVID-19 in the community and determine the spread or distribution of 1) active infection, and 2) past exposure. The hypothesis is that there are many undiagnosed and/or asymptomatic people in the community who may be unknowingly spreading the virus or have been exposed and have antibodies. We propose to implement respondent-driven sampling (RDS) which leverages effort on the part of seed or index cases to recruit contacts for participation.

Purpose and objective: The purpose of this study is to use community sampling to detect active, undiagnosed COVID-19 cases and/or determine the spread or distribution of active infection. The objective is to use a network targeted sampling design to direct testing to yield a higher proportion of results which indicate active infection and possibly differentiating between venues or communities where transmission is active and undiagnosed.

Study activities: A person who tests positive for COVID-19 will be given a set of "tokens" to give to contacts that will entitle these contacts to make an appointment to receive a test for COVID-19.

Population groups: The population group will include people with index cases of COVID-19 and their contacts for the past 14 days. As these contacts are tested and receive positive results, they will be given tokens to hand out to their contacts over the past 14 days. The network of positive cases will "blossom" to reveal community transmission and asymptomatic cases, thus giving researchers an indication of disease prevalence.

Data analysis: At the completion of each epoch and at the end of the study, we will scale the social networks up and conduct network analysis using SAS and the igraph package in R. These analyses will be applied in an ongoing manner to guide selection of seeds in subsequent epochs to ensure representativeness and to guide selection of alters to encourage longer referral chain lengths.

Risk/safety issues: The primary risks include discomfort from the nasal swab and risks from the venous blood draw used in testing and the potential loss of confidentiality. All efforts will be made to securely manage the data to ensure participant confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Positive COVID-19 test result -or- receipt of a coupon from a previous study participant
* Resident of Durham County (for seed participant only)
* Willing to undergo COVID-19 test nasopharyngeal swab for RT-PCR testing and blood draw for COVID-19 antibody testing
* Age 18+
* Speak and understand English

Exclusion Criteria:

* Currently receiving inpatient treatment for COVID-19
* Unable to consent
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)

The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.

The study is randomized, placebo controlled. The study population includes patients older than 18 years of age undergoing elective total primary knee replacement under spinal anesthesia. All patients enrolled in the study will undergo TKA performed by the same orthopedic surgeon. Since controversies exist regarding the effect of different types of anesthesia (general anesthesia versus spinal or epidural anesthesia) on intraoperative blood loss, in order to eliminate an important confounding variable we decided to exclusively enroll for our study patients that qualify for and agree with spinal anesthesia to be used as the main anesthetic technique for their TKA.

All clinical trial procedures will be performed by personnel blinded to study treatment assignment. Unblinding is only allowed for safety concerns in an emergency situation.The only other exception is represented by the surgeon, who can't be blinded in regards to using Aquamantys system and the bipolar sealer. Once a subject becomes eligible for the trial, the investigator or the designee will access the randomization system.

Enrolled subjects will be assigned to one of the 4 groups by block randomization of alternating 4 and 8 and 12 patients per block. The Pharmacy Department will provide the iv placebo or the iv TXA according to the randomization process.

This clinical trial will be conducted in accordance to this protocol, Good Clinical Practice and applicable regulatory requirements

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over age of 18 undergoing elective total primary knee arthroplasty under spinal anesthesia.

Exclusion Criteria:

* Previous adverse reaction to tranexamic acid
* Congenital or acquired coagulation disorders
* Preoperative platelet count of less than 100,000/microliter or INR\> 1.4
* History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident
* Patients with acquired defective color vision
* Renal insufficiency (Glomerular filtration rate \<20 ml/min)
* Severe liver disease
* Coronary stents
* Pregnant patients
* Main anesthetic other than spinal anesthesia
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) \>=7.5% and \<=11% and a Fasting Plasma Glucose (FPG) \>=130 mg/dL and \<=280 mg/dL

Exclusion Criteria :

* Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.

This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).

Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.

Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.

However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.

Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.

There is not enough evidence in pediatric patients that this affirmation is also true.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who are to be submitted to a colostomy closure

Exclusion Criteria:

* patients with more than 3 abdominal surgeries
* patients with primary or acquired immunodeficiencies (including malnourishment)
* Patients in which the distal intestine is closed in a Hartmann´s pouch
Physical Activity and Cardiovascular Risk in Black Girls

To conduct a longitudinal study investigating the physical activity patterns, the psychosocial predictors of physical activity, and the effects of physical activity changes on blood pressure and body fatness in a cohort of African-American girls, ages 11-17.

BACKGROUND:

The study contributed to an underdeveloped area of research. Physical activity is recommended as a nonpharmacological means to modify hypertension and obesity, two cardiovascular risk factors. African-American women have low levels of physical activity and high rates of obesity, hypertension, and mortality from coronary heart disease, diabetes, and hypertensive diseases. In 1992, there was an absence of longitudinal data about the physical activity habits of African-American girls even though a decline in physical activity during adolescence had been reported in other subpopulations.

DESIGN NARRATIVE:

Within the framework of puberty and maturation, the study: 1) described longitudinal patterns of physical activity; 2) assessed longitudinal changes in physical activity and concomitant changes in blood pressure and body fatness; and 3) determined psychosocial predictors of changes in physical activity. The investigators hypothesized that there would be a monotonic decrease in physical activity and that psychosocial variables would predict changes in physical activity. The study population consisted of 189 sixth grade, mostly African-American, girls in Fort Bend Independent School District, Missouri City, Texas. The girls were measured for four and a half years, ages 11 or 12 at entry of the study. Anthropometry, sexual maturation, blood pressure, physical activity habits and psychosocial predictors were measured twice a year for a total of nine examinations. Data on dietary, smoking and drinking habits were collected annually. Activity patterns, psychosocial predictors and other habits were assessed by interviews and questionnaires. Sexual maturation was assessed by menarche and the Tanner stages. Skinfold and circumference measures determined body fatness and body fat distribution.

Eligibility Criteria:
No eligibility criteria
L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients

Immunosuppression is a key intervention in patients with solid organ transplant and is usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine, mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation are poor when compared with those after heart, kidney, or liver transplantation, with a survival rate of only 55% for recipients of lung transplants.

Additional application of aerosolised L-CsA should suppress T-cell activation in the lung tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to obtain efficacy and safety data of L-CsA in the prevention of BOS.

Preventive therapeutic intervention by L-CsA is primarily aimed to suppress T-lymphocyte suppression and inflammatory responses and secondly to prevent fibrotic effects making it more likely to be effective in early stages of BOS. Early development of BOS, which mostly will not be diagnosed, and acute organ rejections are strongly patho-physiological associated. Prevention of the very early development of chronic rejection by L-CsA post LTX may be the ideal starting point for IMP application.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's written informed consent
2. Received a single lung, bilateral lung or heart/lung transplantation between 6 weeks and 26 weeks prior to first IMP administration.
3. Male or female, 18 years of age
4. Capable of self-administration of medications
5. Capable of understanding the purpose and risk of the clinical trial
6. Received the following immunosuppressive agents and dosages for maintenance therapy:

   1. Tacrolimus and
   2. Mycophenolate mofetil (MMF) 1 to 3 g/day and
   3. Prednisone or any other steroid therapy; tapered down
7. Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
8. Estimated life expectancy \> 6 month

Exclusion Criteria:

1. Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
2. Any active invasive bacterial, viral or fungal infection
3. Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria
4. Received any systemic or topical ciclosporin A within
5. Received any systemic or topical Rosuvastatin
6. Current mechanical ventilation
7. Received a lung re-transplantation
8. Pregnant or breast feeding woman
9. Has known hypersensitivity to ciclosporin A
10. Has a serum creatinine value of more than 265 µmol/L (3 mg/dL)
11. Unlikely to comply with visits, inhalation procedures or spirometric measurements
12. Receipt of an investigational drug within 4 weeks prior to first administration of IMP
13. Any co-existing medical condition that in the investigator's judgement
14. Psychiatric disorders or altered mental status
15. Patient was previously enrolled in the present clinical trial
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.


Eligibility Criteria:
Inclusion Criteria:

* Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
* A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
* Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
* Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
* Child in care
* Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of hypersensitivity to any vaccine.
* History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia

Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and over, which refers to cognitive function changes such as memory decline and attention deficit after anesthesia and surgery. In severe cases, personality changes and social behavior decline may also occur, resulting in irreversible cognitive impairment.Previous studies have suggested that cognitive dysfunction after general anesthesia is linked to a genetic disorder of the body clock.Exosomes are cellular forms of cellular microvesicles containing complex RNA and proteins.Exosomes can mediate the expression of genes in the late transcriptional period of the clock system, and directly or indirectly participate in the negative regulation of rhythm expression of minute control genes, playing an important role in the intercellular circadian rhythm information output pathway.Rhythm disorders in the core biological clock system of urinary exosomes and the clock control genes related to kidney can early indicate circadian rhythm changes in the core biological clock system.The sorting and detection of urinary exosome clock information materials in patients has the advantages of easy access, continuous monitoring, early diagnosis and less damage, making urinary exosome a biomarker for the diagnosis and monitoring of circadian rhythm of a good kidney biological clock system.


Eligibility Criteria:
Inclusion Criteria:

* patients whose age ≥ 18 years old and \<90 years of preoperative sleep disorder;
* Primary cancer patients who had not received any radiotherapy or chemotherapy before surgery;
* Surgeries expected to be performed under general anesthesia after ≧3 hours

Exclusion Criteria:

* a history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
* inability to communicate due to coma, severe dementia, language impairment or serious illness;
* critically ill (preoperative ASA (American Society of Anesthesiologists)\>III), Childe-Pugh C or severe renal insufficiency (preoperative dialysis);
* Neurosurgery.
A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years

  * Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
  * FISH with del(17p)/TP53 mutation or ≥65 years; or\<65 years but chemotherapy intolerance;
  * Life expectancy of \> 3 months (in the opinion of the investigator);
  * Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);
  * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
  * Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
  * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Exclusion Criteria:

* Pregnant or lactating women;
* Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
* With acquired or congenital immunodeficiency;
* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
* Known to be allergic to the test drug ingredients;
* Diagnosed with or being treated for malignancy other than lymphoma;
* With severe infection;
* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
* Deemed unsuitable for the group.
OPTIMAL STENTS DURING RENAL COLIC

From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included age (18 to 60 years old),
* confirmed ureteral stone
* prescribed ureteral stent placement for pain syndrome relief

Exclusion Criteria:

* an active urinary tract infection.
Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

Pancreatoduodenectomy is associated with nearly 25% incidence of postoperative complications. One of the most severe complications is a postoperative pancreatic fistula. The exact cause of postoperative fistula development is still unknown, but it appears to be multifactorial. Proper perfusion of pancreatic remnant is essential for the healing of pancreaticojejunostomy. To date, there is no method to reliably evaluate the vascular supply of the remnant. One of the methods for assessment of organ perfusion is the indocyanine green fluorescence. This study aims to determine if indocyanine green fluorescence is a reliable method to measure the perfusion of the post-resection pancreatic remnant. Secondary outcome is to determine, if perioperative evaluation of the vascular supply of the postresection remnant may predict the increased risk of the postoperative pancreatic fistula development.

This study is designed as a prospective experimental study. All consecutive patients undergoing open pancreaticoduodenectomy at our department in the 1.5.2024-31.12.2026 period will be enrolled. Exclusion criteria are allergy to indocyanine green and refusal by the patient.The adequacy of the vascular supply of the post-resection pancreatic remnant will be perioperatively evaluated using fluorescence detector. Patients will be divided into two groups. Those with hazardous and non-hazardous vascular supply. The incidence of pancreatic fistula in both groups is to be compared. Postoperative data including morbidity, mortality, hospital stay, intensive care unit stay and postoperative fistula development will be collected.

If a perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green is proven to be a suitable method to estimate the increased risk of the pancreatic fistula, the list of the existing known risk factors could be expanded. In the most high-risk patients the modification of the surgical procedure could be considered.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period

Exclusion Criteria:

* Allergy to indocyanine green
* Refusal by the patient
* Mini-invasive procedure.