cyrilzakka/clinical-trials huggingface dataset:
ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"

* To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and platelet activation (flow cytometry) with different loading doses of clopidogrel
* To evaluate the effect on various parameters of inflammation and necrosis and the safety of these loading doses


Eligibility Criteria:
Inclusion Criteria:

1. Patient hospitalised with ischemic symptoms (onset \< 48 hours) and at least one of the following characteristics of NSTEMI:

   * ECG ST or T changes
   * positive troponin
2. Patient treated on admission with 250-500 mg aspirin (oral or IV) and who will receive low dose aspirin (\< or = 100 mg daily) from the next day on
3. Patient treated with bid LMWH (indicated dosage for this indication)

Exclusion Criteria:

1. Catheterization scheduled within 24 hours after randomisation
2. Patient presenting an absolute contra-indication to the use of clopidogrel and/or ASA:

   - history of drug allergy to thienopyridine derivatives or ASA
3. Severe uncontrolled hypertension (BP \> 180 / 100 despite therapy)
4. Platelet count \< 100 000 / mm3
5. Neutrophil count \< 1800 / mm3
6. Patient with increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
7. History of severe systemic bleeding
8. Patient with any contraindication to LMWH
9. Patient treated with clopidogrel within the last 10 days
10. Patient treated with oral anticoagulants or hirudin or planned to receive these products during the hospitalisation period
11. Patient treated with ticlopidine, dipyridamol, NSAIDs (including Cox1 and Cox2 inhibitors), cilostazol, GPIIb IIIa antagonists or planned to receive any of these products within the next 24 hours following randomisation.
12. Patient whose arm venous status is incompatible with an indwelling catheter
13. Patient presenting an evolving cancer
14. Patient with NYHA class IV heart failure
15. Intubated and ventilated patient
Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of PF-06835919 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Body Mass Index 21.5 to 30.5 kg/m2 (inclusive);
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

-Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Universal HIV Screening and Targeted HCV Screening in Emergency Department

Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening program for HIV and HCV and prospective follow-up for 3 months of positive cases.

The purpose of this study is to evaluate the feasibility of routine HIV and HCV screening using an "opt-out" approach at the emergency room of the CHUM and to determine the rate of new positive HIV and HCV cases. A sub-analysis will focus more specifically on HCV in the Quebec equivalent of "baby boomers" (1945-1975) since this is the group that was targeted in the United States. The second phase of this study will evaluate the effectiveness of the linkage to the healthcare system for people diagnosed with HIV or HCV and how fast these people are taken care of and put on treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

* Individuals unable to opt-out due to their psychological or physical condition
To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
* All participants of childbearing potential must agree to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.

Exclusion Criteria:

* Pregnant or breastfeeding.
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy

The purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.

This is the randomized controlled, multi-centers，and open-labeled study. The lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (NAT), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. Carbon nanoparticle (CNP) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. The inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection CNP before NAT and no injection CNP before NAT. In this study, the participants with clinical TNM stage T3+ or N+ will be recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will not receive injection of any kind lymph node tracers. The participants in the intervention arm will receive injection of CNP before NAT. And the specimen would be evaluated by the pathologist.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years old;
2. Histologically confirmed adenocarcinoma;
3. The rectal adenocarcinoma 0-12cm from the anal margin;
4. Clinical TNM stage: T3+ or N+;
5. Untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery);
6. Good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery;
7. Able and willing to give informed consent to participate;

Exclusion Criteria:

1. Malignant tumor history or other malignant tumors;
2. Emergency operations such as intestinal obstruction, perforation and hemorrhage;
3. Pregnant or lactating women;
4. History of severe mental illness;
5. Contraindications for radiotherapy, chemotherapy and surgery;
6. Conditions that the researcher thinks it is not suitable for selection.
Clonazepam in Children Status Epilepticus

•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.

The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).

To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.

Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus

•Methods: Monocentric retrospective study including children \< 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.

The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.

•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.

Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.

About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.

To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.


Eligibility Criteria:
Inclusion criteria:

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged under 16 years
* Status epilepticus taken care of at the CHU de Montpellier

Exclusion criteria

● No loading dose of clonazepam
Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol

The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

In this study we will describe

* habits of medical staff in prescription of growth factors or antibiotic prophylaxis
* ratio of patients treated by growth factors in primary or secondary prophylaxis
* ratio of patients treated in primary prophylaxis who present a febrile neutropenia
* ratio of patients who need to be hospitalized and the duration of those hospitalizations.
* causes of lateness, of decreasing, and of stop of chemotherapy
* antibiotic and growth factors prophylaxis tolerance .

Eligibility Criteria:
Inclusion Criteria:

* patients with histologically proved head and neck squamous cell carcinoma
* age: more than 18
* patients who are beginning a chemotherapy (docetaxel+cisplatin+ 5FU)
* patients must have been informed of automatic data processing concerning them.

Exclusion Criteria:

* previous chemotherapy for the head and neck squamous cell carcinoma
* previous chemotherapy for an other cancer in the two years before
* intercurrent illness that could significantly interfere with chemotherapy such as HIV infection, infection or active febrile illness, a chronic intestinal disease
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma

The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who received one previous therapy.

Patients will receive study treatment (masitinib/placebo) with the standard therapy (bortezomib and dexamethazone).

Eligibility Criteria:
Inclusion Criteria:

1. Patient with confirmed multiple myeloma requiring systemic therapy. A
2. Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment
3. Patient with measurable progressive disease

Exclusion Criteria:

1. Patient with peripheral neuropathy Grade \>2
2. Patient with hypersensitivity to bortezomib, boron or dexamethasone
3. Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
4. Patient who received bortezomib within 6 months of randomization to this study
5. Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
6. Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Evaluation of the Gambling Habits of Adolescents and Young Adults Post-COVID-19 and Implementation of a Digital Escape Room Intervention for Preventing Gambling in High School Students

Gambling behaviors among adolescents and young adults have been experiencing an upward trend in the last years, possibly because of new habits developed during the COVID-19 lockdown restrictions. Different preventive strategies have been proposed: universal classroom-based interventions have shown promising evidence as preventive tools, but challenges exist in engaging the target audience effectively. Serious games, i.e., those designed with the specific intent to educate, broaden knowledge, and change behaviors, have been tested with positive outcomes. Digital escape rooms constitute a modality of serious game that has shown potential for a variety of educational purposes, but their efficacy for preventing addictive behaviors, as well as their long-term impact, has not been widely studied.

The present project aims at assessing the gambling habits of a sample of 16-25-year-olds in the region of Aragon, Spain, that could be compared to the data gathered before the pandemic started, so not only the prevalence rates can be updated but also potential differences in habits (e.g., preferred gambling alternatives) can be detected. This will undoubtedly help the design of effective preventive measures, such as the GAMBL-OUT digital escape room, a serious game to be implemented in high schools with the aim of increasing knowledge, reducing intentions to gamble, and changing attitudes towards gambling.


Eligibility Criteria:
Inclusion Criteria:

* Only high school students aged between 16 and 18
* Being able to read and understand the Spanish language
* Willingness to participate in the study and sign the written informed consent form

Exclusion Criteria:

* Age: \<16 years old, or \>18 years old
Postpartum Depression: Transdermal Estradiol Versus Sertraline

The purpose of this study is to determine whether estrogen patches are effective for the treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.

This study aims to advance our therapeutic armamentarium by evaluating the efficacy of estradiol (E2) therapy for Postpartum Major Depression (PPMD), which has received minimal research attention in America. The design of the proposed study is an 8 week randomized double-blind clinical trial of SERT vs. E2 vs. Placebo. Responders enter a continuation phase with the blind intact through 6.5 months postpartum. The primary aims of this investigation are to: 1) Test the efficacy of E2 compared to placebo for the treatment of PPMD. Sertraline will be included as an active comparator. We have powered the study to test for differences among the three groups and also test for differences between the E2 and placebo group. We will test the hypothesis that E2 will be significantly more effective than placebo and that SERT will be significantly more effective than placebo. 2) Evaluate developmental outcomes in infants exposed to the disorder, PPMD, and the medications (SERT, exogenous E2 or Placebo) which may be transmitted to the infants through breastfeeding. All infants in this study will have exposure to mothers with depression. We will assess maternal depression, mother-infant serum SERT and E2 levels and relate them to mother-infant interactional quality and infant developmental outcomes on the Bayley Scales of Infant Development. These data will enhance the sophistication of risk-benefit analyses for pharmacotherapy during lactation.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-45 years
* Had a baby within the last 3 months
* Experiencing depression or lasting sadness

Exclusion Criteria:

* Current use of other therapies for depression, such as antidepressants, psychotherapy, bright light therapy, and herbal remedies such as Hypericum St. John's Wort
* DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse within last 6 months
* Previous adverse reaction to sertraline or provera
* No pediatric care: No pediatrician with whom to coordinate breastfeeding and infant care
* Use of medications for medical disorders, except for treatment of hypothyroidism or inhalers for asthma or progestin-only contraceptives
* Heavy smoking (\>10 cigarettes per day) or intent to resume heavy smoking (unless willing to cut down)
* personal history of thromboembolic event, hypercoagulability, or first degree relatives with thromboembolic events.
* Current or past personal history of breast, uterine, or ovarian cancer.
* BRCA-positive mother
* Arterial vascular disease and/or heart disease: increased risk of stroke.
* Liver disease: increased risk of biliary stones, cholestatic jaundice and benign hepatic lesions with E2 treatment.
* Diabetes
* Pregnancy
* Infants born \<32 weeks of gestation
* Imminent suicidality and/or homicidality: in need of higher level of care than is provided in this study.
"The Impact of Digitalization Education Provided to Nursing Students on Their Attitudes Towards Telemedicine"

This research was conducted as a pre-test post-test design in a randomized controlled study. Participants were given a 5-week telemedicine education related to nursing care, and the changes in students' attitudes toward telemedicine were examined. Digitalization has brought about significant changes in healthcare, and telemedicine applications have enabled nurses to transform patient care. Improving nursing students' knowledge and attitudes toward telehealth is crucial for enhancing the effective use of digital health tools. In this context, the "The Role of Digitalization in Nursing: An Innovative Transformation in Care" training program was designed to assess nursing students' attitudes toward telemedicine applications. The study aims to analyze the impact of the training program by comparing experimental and control groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older,
* Currently enrolled as an active student in the Nursing Department,
* A third-year student in the Nursing Department,
* Agreement to participate in the study.

Exclusion Criteria:

* Having hearing or speech impairments,
* Diagnosed with a psychotic disorder,
* Participating in another psychosocial intervention program.
Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis

The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.

The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 70 years
* Bilateral tibiofemoral osteoarthritis of the knee on x-ray
* American College of Rheumatology (ACR) clinical classification criteria

Exclusion Criteria:

* Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases
* Excess alcohol use (\> 21 alcoholic drinks per week)
* Severe overweight (BMI \> 35)
* History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

* improve sleep thereby decreasing need for opiates via PCA
* improve sleep thereby decreasing pain by self report
* improve sleep thereby decreasing fatigue by self report

Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.

One of the less commonly recognized side effects of opiate use is sleep disruption.

Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.

Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
2. Age 20 - 75
3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
4. Can tolerate oral medication.

Exclusion Criteria:

1. Patients with a current history of substance abuse
2. Patients with a history of allergic response to Lunesta.
3. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.