cyrilzakka/clinical-trials huggingface dataset:
Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer

Bladder cancer (BC) is one of the most common type of cancer globally. Due to its high incidence rate, high risk of recurrence and progression, and frequent cystoscopy surveillance, BC contributes to major healthcare costs across the world. The goal of this prospective study was to evaluate the prognostic value of novel non-muscle invasive bladder cancer (NMIBC) biomarkers for predicting disease recurrence or progression after radical transurethral resection of bladder tumour (TURBT). The data obtained from this study may help physicians identify patients who are at greater risk of NMIBC recurrence or progression and require close supervision.

The aim of our prospective study was to determine the prognostic impact of the inflammatory response and indicators of nutritional status on recurrence and progression of non-muscle invasive bladder cancer (NMIBC) in patients undergoing transurethral resection of bladder tumour (TURBT). We evaluated six biomarkers, 3 in blood serum: soluble urokinase plasminogen activator receptor (sUPAR), plasminogen activator inhibitor-1 (PAI-1), interleukin 8 (IL-8) and 3 in urine: apolipoprotein E (APOE), vascular endothelial growth factor (VEGF), interleukin 8 (IL-8). Furthermore, following indicators of nutritional status were investigated: Glasgow Prognostic Score (GPS) and Modified Glasgow Prognostic Score (mGPS).

The primary endpoint of this study was the recurrence or progression of NMIBC based on the histopathological or cystoscopic result. The study outcome was evaluated during the first surveillance cystoscopy, which was performed in time intervals indicated by European Association of Urology. Based on literature data and statistical assumptions we aimed to recruit 240 patients with NMIBC.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Presence or suspicion of tumour in urinary bladder
* Qualification for the first transurethral resection of bladder tumour

Exclusion Criteria:

1. age \< 18 years
2. active urinary tract infection
3. active autoimmune disease
4. end-stage renal failure and renal replacement therapy
5. active hepatitis A, B or C
6. active HIV infection
7. pregnancy
8. factors disqualifying the patient from adjuvant treatment (intravesical immunotherapy or intravesical chemotherapy)
9. bladder tumour stage T2 or more, or urothelial tumour in a location other than the urinary bladder
10. other cancer or systemic anticancer treatment carried out up to 5 years ago
11. factors disqualifying the patient from surgical treatment, e.g. coagulopathies
12. lack of patient consent to collection of blood and urine samples and to follow-up visits
The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS

Maintaining the normal function of the pulmonary microvascular barrier is critical for ARDS treatment. To assess the relationship between the HAS2 protein level, HA content and the clinical prognosis of ARDS in patients with ARDS. Compare the HAS2 protein levels, HMW-HA and LMW-HA levels, endothelial injury indicators, and lungs in the blood of severe and non-ARDS severe patients and healthy adults admitted to the ICU. The correlation between permeability, disease severity and prognosis to explore the predictability of HAS2-HA on the clinical outcome of ARDS.


Eligibility Criteria:
Inclusion Criteria:

1.85 years≥Age≥18 years. 2.Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \[PaO2\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O).

3.Diagnosis of ARDS less than 72 hours.

Exclusion Criteria:

All patients who meet any of the following criteria will be excluded at enrollment and randomization.

1. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV.
2. Undrained pneumothorax or subcutaneous emphysema.
3. Severe neuromuscular disease.
4. Hemodynamic instability (\>30% increase in vasopressors within 6 hours or norepinephrine \>0.5 ug/kg/min) (Am J Respir Crit Care Med. 2020; 201(2):178-187) .
5. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome.
6. Severe other organs dysfunction with a low expected survival (7 days) or palliative care.
7. Solid organ or hematologic tumors with the expected survival time less than 30 days.
8. Participating in other clinical trials within 30 days.
9. Pregnancy.
10. Refusal to sign the informed consent.
Safety and Efficacy of Paclitax Coated Balloon in Patients with Coronary In-stent Restenosis (ISR)

The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.

The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.

260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.

All enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test.

Eligibility Criteria:
Inclusion Criteria:

① Age ≥18 years old.

② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.

③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.

Exclusion Criteria:

* A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.

  * Patients with life expectancy less than 1 year.

    * Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.

      * Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.
Shortened High-dose Palliative Radiotherapy for Lung Cancer

The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions), aided by contemporary RT planning, verification, and delivery techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patient has locally advanced (stage IIIB or IIIC) or metastatic (stage IV) NSCLC
* Patient is treatment naïve or had limited progression after first-line systemic therapy (using chemotherapy, immunotherapy, or targeted therapy)
* Patient is suitable for high dose palliative RT (36Gy in 12# or 39Gy in 13#)
* Obtained written informed consent for the SHiP-Rt study.
* Patients receiving RT after first-line systemic therapy must have a wash-out period of at least 3 weeks (i.e., 3-4 weeks).
* Treatment naïve patients should be able to proceed to definitive systemic therapy without undue delay, i.e., within 3-4 weeks.

Exclusion Criteria:

* Contraindication for thoracic RT
* Requiring lung RT after second-line systemic therapy for NSCLC
* Has more than 1 cancer that is requiring active treatment
* On cytotoxic treatment for rheumatoid arthritis or connective tissue disorders
* Poor life expectancy, likely less than 6 months
* Patients with difficulty regarding compliance to the study treatment or follow-up
* Previous radiotherapy to the same area
The Impact of Sage Extract on GTS B and D Gene Expression in S. Mutans

Glucosyltransferases (Gtfs) play a crucial role in the pathogenesis of dental caries caused by Streptococcus mutans. Gtfs is recognized as an attractive target for effective therapeutic interventions aimed at inhibiting cariogenic biofilms.

Objective: This study evaluates the antibacterial effects of sage extract compared to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from salivary samples of high caries risk patients over a one-month follow-up, utilizing real-time polymerase chain reaction.

Methodology: This clinical trial involves 42 participants with a high risk for caries, who are randomly divided into two groups of 21 subjects each.

Glucosyltransferases (Gtfs) are essential in the development of dental caries caused by Streptococcus mutans. They are currently recognized as promising targets for effective therapeutic strategies aimed at disrupting cariogenic biofilms.

Objective: This study investigates the antibacterial effects of sage extract in comparison to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from the saliva of patients at high risk for caries, over a one-month follow-up period, using real-time polymerase chain reaction.

Methodology: This clinical trial includes 42 high caries risk participants, who are randomly assigned to two groups, each consisting of 21 subjects.

Eligibility Criteria:
Inclusion Criteria:

* medically free, high caries patient with DMFT

Exclusion Criteria:

* pregnant and smokers
Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993).

Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another.

Individual heterogeneity in the immune response can have an enormous impact on the likelihood to respond to therapy or the development of side effects secondary to vaccine administration. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that constitute a healthy immune system and its natural occurring variability.

The overall aim of the Milieu Intérieur study (NCT03905993) is to define the parameters that characterise a healthy immune response and its natural variation across individuals, and in doing so, inform clinical strategies for managing disease. To achieve this, in 2012, a total of 1000 healthy volunteers, descendants of mainland French persons for at least three generations, split equally by sex (1:1 sex ratio) and stratified across five-decades of life were recruited.

With the first data collection (clinical study), key fundamental insights were gained. The project has also established a rich sample and data repository, supporting ongoing integrative research in systems immunology and personalized medicine.

To provide a longitudinal assessment of the immune variation observed in the Milieu Intérieur cohort, this research aim to perform a follow-up study of the cohort, 10 years after the initial study.

Eligibility Criteria:
Inclusion Criteria:

* Any individual that provided samples for the initial Milieu Intérieur study (NCT03905993)
* Ability to give their informed consent in writing
* Subjects who, according to the investigator, can and will comply with the requirements of the protocol.
* Affiliated to the French social security or assimilated regimens

Exclusion Criteria:

* Individuals benefiting from a legal protection measure
* Individuals unable to express informed consent for participation
* Pregnant and breastfeeding women
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.

Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.

A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females at least 18 years of age.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and ll).

Exclusion Criteria:

* Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
* Any history ofa clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IDD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in children who have hospitalized for acute wheezing.

Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.

Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the hospital for acute wheezing.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Children who have recurrent wheezing attacks
* Children who admitted to the hospital for acute wheezing
* Clinical asthma score of 3-9
* Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Immunodeficiency
* Cardiac disease requiring surgery or medications
* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
* Known renal or hepatic dysfunction
* Impending respiratory failure requiring positive pressure ventilation
* Immune deficiency
* Gastroesophageal reflux disease
* Suspected foreign body aspiration or croup
* Anatomic abnormalities of the respiratory tract
ACT for Infertility: Case Series

In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.

In this study, the investigators present Acceptance and Commitment Therapy (ACT) as a potentially well-suited intervention for infertility patients, and they highlight mechanisms and processes through which ACT might benefit patients. They present a series of cases in which the therapist uses an ACT approach to treat individuals diagnosed with infertility.

The Duke University Health System includes a fertility clinic, which houses an embedded clinical psychology team. Patients at the fertility center can participate in individual psychotherapy and/ or group psychotherapy as part of their fertility treatment. An interventionist will provide psychotherapy to up to 10 individuals on the therapy waitlist. Patients will be eligible for the study if they: are at least 18 years old, have a diagnosis of infertility, speak English, and are not already participating in individual therapy. Patients will be excluded from the study if they endorse current suicidality and/ or self-harming behavior, current psychosis symptoms, and/ or current substance use.

For those that enroll in the study, patients will complete 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. Although sessions will vary across individuals, the therapist will aim to target the six core ACT processes in all cases. The therapist will offer both in-person and virtual sessions. Participants will complete a subset of questionnaires at each study session.

Eligibility Criteria:
Inclusion Criteria: Patients will be eligible if they

* are at least 18 years old
* have a diagnosis of infertility
* speak English
* are not already participating in individual therapy.

Exclusion Criteria: Patients will be excluded from the study if they

* endorse current suicidality and/ or self-harming behavior
* current psychosis symptoms
* and/ or current substance use
Evaluating High-flow Nasal Cannula Oxygen Therapy Through LUS During Weaning

Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS). Investigators have recently demonstrated in a prospective two-center study of 100 patients that the intensity of the lung aeration loss occurring during the weaning trial, was predictive of the development of postextubation respiratory distress within 48 hours following extubation. A LUS ≥ 14 could identify patients at high risk of developing postextubation respiratory distress. A second study that investigators have just completed in 80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group.

The establishment of a targeted therapeutic strategy proposed in a group of high-risk patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the incidence of extubation failure and associated morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* patients above 18, mechanically ventilated on tracheal intubation for more than 48 hours.

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease (COPD) with moderate to severe (3 and 4) stage defined by a forced expiratory volume in one second (FEV) \<50% of theoretical value
* Patients with previous chronic respiratory disease
* Paraplegia with level\> T8,
* Severe ICU-acquired neuromyopathy
* Patients with tracheostomy for any reason.
TXA vs. Amicar in Total Knee and Hip Arthroplasty

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.

Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.

Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.

A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.


Eligibility Criteria:
Inclusion Criteria:

* Patients electing to undergo primary total hip or knee arthroplasty

Exclusion Criteria:

* History of stents
* Myocardial infarction,
* Cerebrovascular accident or stroke
* Deep venous thrombus
* Pulmonary embolus
* Late onset color blindness
* Hypercoagulable state