cyrilzakka/clinical-trials huggingface dataset:
Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication

The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department.

The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.

Pharmaceutical means for clinical pharmacy activities and pharmaceutical analysis are limited. Several methods can be used to increase the efficiency of resources allocated to clinical pharmacy activities. We hypothesize that highlighting patients at risk for iatrogenic drug events (ADEs) by applying a predictive score of ADE could be a way to increase the efficiency of clinician pharmacist interventions.

b. Assumption (s) and objective (s) The use of a predictive score of ADE in hospitalized patients in orthopedic surgery would make it possible to prioritize clinical pharmacy actions according to the resources allocated. The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The secondary objective is to evaluate its superiority over other predictive models such as the age or the Physical Status Score physical status score used by anesthetists.

c. Methodology The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions (NPS) using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.

d. Expected results and prospects The usefulness of clinical pharmacy activities is now demonstrated, however an improvement in their efficiency is needed. The prospects are the integration of the risk score in the dispensing assistance software connected to the computerized patient record as well as extending the score to other types of surgery.

Eligibility Criteria:
Inclusion criteria:

* Subject aged over 18 years
* Subject hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier.

Exclusion criteria:

* Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)
FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis

Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease
* Renal pathology was performed within 2 weeks

Exclusion Criteria:

* Pregnant or lactating patients
Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.

This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed angioimmunoblastic T cell lymphoma
2. Treatment naive
3. Age \> 18 years
4. Must has measurable lesion in CT or PET-CT prior to treatment
5. ECOG 0,1,2
6. Informed consented

Exclusion Criteria:

1. Has accepted Chemotherapy before
2. Has accepted autologous Stem cell transplantation before
3. History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
4. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
5. Primary CNS lymphoma
6. LVEF≤50%
7. Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<75\*10\^9/L; ALT or AST \>2\*ULN; AKP or bilirubin \>1.5\*ULN ;Creatinine\>1.5\*ULN
8. Other uncontrollable medical condition that may that may interfere the participation of the study
9. Not able to comply to the protocol for mental or other unknown reasons
10. Pregnant or lactation
11. HIV infection
12. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma

The proposed study will test the safety and efficacy of sodium valproate in the induction of Epstein-Barr virus (EBV) lytic cycle antigen expression in tumor tissue of patients undergoing primary therapy for nasopharyngeal carcinoma. Up to 20 patients will be given valproic acid for 2 weeks. The primary surrogate endpoint for efficacy will be expression of EBV lytic antigens by immunohistochemistry in tumor tissue. Biopsies of primary tumor will be taken after 2 weeks with achievement of a therapeutic concentration of valproate. Expression of immunodominant EBV latency antigens in tumor tissue, EBV viral load by real time PCR, and valproate levels will be measured. Adverse events associated with valproate in NPC patients will be described.


Eligibility Criteria:
Inclusion Criteria:

All subjects must fulfill the following criteria to be eligible for study admission:

* Subjects are of age 18 years and above
* Biopsy proven nasopharyngeal carcinoma - WHO type 3
* Must have tumor which is accessible to biopsy
* For patients with disease localized to the PNS, the lesion must be visualized by endoscopy
* Subjects with metastatic disease with disease accessible to biopsy in the PNS if they are deemed by their treating physicians not to require treatment for at least two weeks.
* An ECOG performance status of 0-2
* For sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial
* Must be able to give informed consent

Exclusion Criteria:

* For patients with localized NPC, PNS lesions that cannot be visualized by endoscopy
* Patients with disease inaccessible to biopsy
* History of anaphylaxis after exposure to valproic acid
* Hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. AST (SGOT) and ALT (SGPT) 3x upper limit of normal
* Hemoglobin 8g/dl, Absolute neutrophil count 1500 cells/mm, and Platelet count 100,000 /mm
* Creatinine 3x upper limit of normal
* PT/PTT blood test result not within normal range
* Patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol
* ECOG Performance status 3-4
* Patients who are pregnant or breast feeding (Sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial)
* Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with T2DM failing metformin monotherapy
* Between the ages of 18 and 79

Exclusion Criteria:

* Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans

The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.

Twelve healthy volunteers will undergo antroduodenojejunal manometry. Baseline recording with infusion of saline for 1 hour is compared with infusion of GLP-1 0.7 and 1.2 pmol per kg minute for another 1 hour. Plasma GLP-1 and GLP-2 is measured by RIA. Responses to GLP-1 will be measured after food intake as prandial response to GLP-1. The outcome will be evaluated as change in motility index from baseline to meal-stimulated conditions and during influence of GLP-1. Further in vitro studies of gastrointestinal muscle strips, precontracted with bethanechol or electric field stimulation, are planned to investigate the response to GLP-1 or GLP-1 analogue ROSE-010. GLP-1 and GLP-2 receptor immunoreactivity is localized by immunohistochemistry. Receptor mediated mechanisms are studied with GLP-1 receptor blocker exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin to block sodium channels and nerve conduction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers over 18 years of age.

Exclusion Criteria:

* Any medical condition.
* Any drug treatment.
Diet and Exercise Intervention in Type 2 Diabetes

The purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.

The purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).

Eligibility Criteria:
Inclusion Criteria:

1. Age 25-68 yrs old
2. BMI 27.0-50.0 kg/m²
3. Diagnosis of type 2 diabetes based on HbA1C\>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
4. HbA1C ≤9.5 %.
5. Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.

Exclusion Criteria:

1. Any change in diabetes medication in previous 3 months
2. Treated with \>0.5 units of insulin/kg body weight per day
3. Unstable weight (\>2% change during the last 2 months before entering the study)
4. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
5. Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
6. Creatinine \>1.5 mg/dL
7. Microalbuminuria; spot urine albumin:creatinine ratio \>50 (50 μg albumin/mg creatinine)
8. Coagulation disorders
9. Anemia (Hemoglobin \<10.0 g/dL)
10. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
11. Uncontrolled proliferative diabetic retinopathy
12. Severe peripheral neuropathy diagnosed by monofilament testing
13. Severe organ dysfunction
14. Pregnant or breastfeeding
15. Participating in regular exercise (\>1 h of structured exercise/week)
16. Joint replacement within the last year
17. Smokes tobacco
18. Severe lactose intolerance
19. Take any medication that might interfere with interpretation of the metabolic studies
20. Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
An Interactive School Sleep Education Program

The aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective in improving students' sleep behavior and corresponding outcomes.

The present study aims to examine the effectiveness of a class-based interactive Sleep Education Program in improving sleep behavior of secondary school students. The Sleep Education Program is designed by sleep experts from our laboratory, and is aimed at educating students about the importance of sleep and good sleep habits, as well as addressing their attitudes towards sleep, in order to encourage behavior change. Participants will be randomly assigned to the Sleep Education Program or a Control Program. All participants will undergo four weekly class-based lessons, which use video presentations, in-class activities, discussions and take-home assignments to deliver the materials. Each lesson has set goals to achieve. Participants in the Sleep Education Program will learn about the importance of sleep, what factors may prevent them from getting enough sleep, how they can manage their time to create more opportunity for sleep, and how they can overcome obstacles to time management. Emphasis will be placed on how sleep affects each student personally, and how each person can benefit from improving sleep. Participants in the Control Program will undergo a similarly structured class-based program, during which they will learn about various general health-related topics. However, the Control Program is designed in such a way that it does not cover any topics related to sleep. Data will be collected from participants from both groups. The following variables are measured: sleep habits, sleep knowledge, daytime functioning, mood and app-tracked time use. Data on all measurements will be collected at three time points: pre-program, immediately post-program and during a 1-month follow-up. Results will be compared between the three time points, as well as between the two groups (Sleep Education Program and Control Program). By comparing results from the Sleep Education Program to the Control Program, we can evaluate the effect of educating students about sleep on improving sleep behavior.

Eligibility Criteria:
Inclusion Criteria:

* Secondary school students
* Currently in year 2

Exclusion Criteria:

* Secondary school students form years other than year 2
Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.

In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children more than 2 days after birth at term and less than 5 years of age
* Patient intubated in the PICU with a cuffed endotracheal tube
* Predicted duration of mechanical ventilation \> or = 24-hours
* Signed informed consent

Exclusion Criteria:

* Intubated with an uncuffed endotracheal tube
* Children admitted to the PICU with a previous tracheostomy
* Preterm children or infants less than 2 days post-term
* Patient under block neuromuscular treatment
* Patient enrolled in another trial that might influence this study results
Pharmacokinetic Interaction Between Nevirapine and Saquinavir-sgc in HIV-1 Infected Patients

The objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. This study will also evaluate the pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical controls treated with nevirapine but without saquinavir-sgc.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western blot
* Patients who meet the following laboratory parameters:

  * Granulocyte count ≥ 1000 cells/mm3
  * Hemoglobin ≥ 9.0 g(dL (men and women)
  * Platelet count ≥ 75,000 cells/mm3
  * Alkaline phosphatase ≤ 3.0 times the upper limit of normal
  * Serum glutamic oxalo-acetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 times the upper limit of normal
  * Total bilirubin ≤ 1.5 times the upper limit of normal
* Patients receiving a stable antiretroviral regimen, including saquinavir-sgc (Fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1
* Female patients of childbearing potential must be willing to use a reliable form of contraception, which should include a medically approved form of barrier contraception
* Patients able to provide written informed consent and comply with study requirements
* Patients with a viral load less than 400 copies/mL

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding
* Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. Such substances in these categories include macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin
* Patients with previous exposure to (or are currently being treated with) non-nucleoside reverse transcriptase inhibitors (NNRTIs)
* Patients receiving a protease inhibitor other than saquinavir-sgc (Fortovase®) in the 28 days prior to visit 1
* Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment in the 12 weeks prior to visit 1
* Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
* Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
* Patients undergoing treatment for an active infection
* Patients who are heavy smokers (≥ 20 cigarettes or cigars per day)
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI

Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Eligibility Criteria:
Inclusion Criteria:

* Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation.

Exclusion Criteria:

* Cardiogenic shock (systolic blood pressure \< 90 mm Hg requiring vasopressor or hemodynamic support)
* Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) \> 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
* Recent gastrointestinal bleeding within the last 30 days.
* Known thrombocytopenia (platelet count \< 100,000/mm3).
* Any treatment with a fibrinolytic agent within the last 7 days.
LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)

Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency \& severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists

- Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly occured upper GI symptoms related to GERD
Impact of Positive Mental Vs. Physical Health Messaging on Motivation to Stop Smoking

This study tested whether positive messages on tobacco packaging about the mental health benefits of quitting smoking could help motivate people to stop smoking. It compared three types of labels: ones focusing on mental health benefits, ones focusing on physical health benefits, and blank labels.

The experiment involved 631 people who smoke who were randomly shown one of these label types on an online survey platform. Participants' motivation to quit smoking was measured before and after viewing the labels.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported weekly tobacco smokers
2. Aged at least 18 years
3. Could read English

Exclusion Criteria:

Did not smoke tobacco at least weekly