cyrilzakka/clinical-trials huggingface dataset:
Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA

intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

OPHELIE is a multicenter study conducted in France in 25 centers where patients treated by iv rt-PA will be included. Patients are treated according to the local protocol, without any modification specifically for this study. A sample of 2 drops of the rt-PA used for the treatment is stored for analysis, to determine the sc-tPA/tc-tPA ration (immunostaining).

700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified Rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%.

The participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. Assuming that 70% will be eligible, the recruitment should take less than 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Being treated by iv tPA for acute cerebral ischaemia

Exclusion Criteria:

* absence of reliable informant
* no rtPA left in the syringe after treatment
A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty

To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty

The pain after knee arthroplasty limits the patient's activities and postoperative recovery, and currently there are mainly three analgesic methods: intravenous analgesia, epidural analgesia and nerve block analgesia. There is a lack of studies on whether liposomal bupivacaine, if used for ACB and iPACK block, can achieve benefits in knee arthroplasty pain management by prolonging sensory nerve block without affecting muscle strength, improving patient prognosis, and shortening hospitalization days.

In this study, in order to better evaluate the effect of liposomal bupivacaine for ACB and iPACK biock on the prognosis of patients undergoing knee arthroplasty, not only the NRS and AUC of patients in each group will be observed, but also the postoperative QoR-15 Quality of Recovery Rating Scale, postoperative nausea, vomiting and other complications, and the number of hospitalization days will be also included as observation indicators. The completion of this study can provide a clinical basis for the selection of analgesic regimens for knee arthroplasty, and also provide strong evidence-based medical support for the relevant medical decision making of government departments.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-79 years.
2. Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
3. Normal diet.
4. ASA grade I\~Ⅲ;
5. BMI 18-30kg /m2.
6. No intraspinal anesthesia contraindications.

Exclusion Criteria:

1. Patients with severe neurological diseases.
2. Hearing and speech impaired.
3. Preoperative gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery, etc.
4. Patients with severe renal insufficiency or other severe metabolic diseases.
5. Mental disorders, alcoholism or a history of drug abuse.
6. The surgical time is greater than 3 hours.
7. Puncture site infection, abnormal coagulation function, and local anesthetic allergy.
TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds

The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception
* NLFs classified as WSRS grade 3 or 4 (same score for each side)
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and likely to complete all required visits;
* Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form

Exclusion Criteria:

* Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control
* Known hypersensitivity/allergy to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock
* Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
* Clinically significant active skin disease within 6 months
* History of active chronic debilitating systemic disease
* History of connective tissue disease
* History of malignancy (excl. non-melanoma skin cancer) within past 5 years
* History of bleeding disorders
* Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit
* Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery)
* Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
* Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas
* A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation
Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas

Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas

In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by 18F-FDG PET (PET/CT and PET/MR). Prior to treatment, all patients will undergo whole-body 18F-FDG PET/CT and PET/MR. The methods' efficiency was compared in the diagnosis of lymph node (LN) and organ involvement.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as lymphoma; Written informed consent for receiving PET/MRI after PET/CT examinations. cancer planned chemotherapy or immunotherapy scheme. expected survival ≥ 12 weeks

Exclusion Criteria:

* cannot lie supine for half an hour; refuse to join the clinical researcher; severe liver or kidney dysfunction pregnancy or lactation
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
* The availability of sufficient plasma
* Age ≥ 21 years
* WHO performance status ≤ 2
* Life expectancy of ≥ 21 weeks
* Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):

  1. Adequate bone marrow function as shown by: ANC ≥ 1.0x10\^9/L, Platelets ≥ 75x10\^9/L, Hb ≥ 7.5 g/dL
  2. Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤ 3.0xULN if liver metastases are present)
* Willing to provide signed informed consent
* Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis within the study team, for potential enrolment

Exclusion Criteria:

* Received more than 2 prior ALK inhibitors (ALKi)
* Symptomatic or uncontrolled brain metastases requiring concurrent treatment inclusive but not limited to surgery and radiation. Stable/ tailing doses of corticosteroids is permitted
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
* Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular disease in the past 6 months.
* Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
* Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
* Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.

On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.

On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18-75 years of age at time of screening
2. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
3. Subject is using insulin to treat their diabetes
4. Subject agrees to comply with the study protocol requirements
5. Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST

Exclusion Criteria:

1. Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen
2. Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder.
3. Subject is unable to tolerate tape adhesive in the area of sensor placement
4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
5. Subject is actively participating in or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device
6. Subject has a positive urine pregnancy test at time of screening
7. Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study
8. Subject is unwilling to participate in study procedures.
Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation

The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug Administration to treat rheumatoid arthritis, may help blood pressure medications to work better. This will be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. We expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
* having a systolic blood pressure \>150 mmHg in the clinic and daytime average \>150 mmHg on ambulatory blood pressure monitoring

Exclusion Criteria:

* Medical history of secondary cause of hypertension, severe obesity (BMI \>35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
* Inability to return for abatacept treatment and follow-up for 24 weeks.
* Inability to understand or complete study-related assessments.
* Current abuse of drugs or alcohol.
* Receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
* Evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (HIV)
* Risk for tuberculosis
* Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin \< 8.5 g/dL, white blood cell count \< 3000/mm3, platelets \< 100,000/mm3, creatinine \> 2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase \> 2 times the ULN.
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
* Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population

The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.

Planned course of the project:

1. We make the questionnaire using Google Forms.
2. The link of the online questionnaire is sent to three public groups via the social media website Facebook.
3. By clicking on the sent link, all participants are able to read information about the project and about the consent to participate in it. Then the participant will be able to give consent to participate in the project. After giving consent, the participant will be able to start filling out the questionnaire. If the participant indicates that he/she does not want to give consent to the study, the website will indicate that the participation of him/her has ended in the project.
4. Anonymous answers will be automatically saved.
5. The participants will be given code numbers based on the order in which they filled out the questionnaire.
6. The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.

Eligibility Criteria:
Inclusion Criteria:

The participant must have access to the internet and to the social media website Facebook.

Exclusion Criteria:

none
Contractubex Treatment in Scars After Abdominal Caesarean Section

The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean section compared to untreated scars after abdominal Caesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Females having given birth via elective abdominal Caesarean section for the first time within the last 5 to 10 days who had their suture removed (removed at screening).
* Age: 18 years or older.
* The subject must be willing and must be able to complete the entire course of the trial and to comply with the trial instructions.
* Written informed consent has been obtained from the subject.
* Females using suitable contraceptions.

Exclusion Criteria:

* Use of any inadmissible medication, e.g. systemic corticosteroids, systemic immunosuppressants (such as cytostatics, therapy with antibodies, biologics, interferone, mykophenolatmofetil, methotrexate, cyclosporine, azathioprine). Any additional topical treatment in the area of the lower abdomen, regardless of the mode of action.
* Any other planned topical treatment in the lower part of the abdomen during the course of the trial.
* Any infection or wound in the area to treat.
* History of keloids or hypertrophic scars.
* Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection.
* Any tumor diseases in the abdominal region independent of their dignity.
* Females having given birth via emergency abdominal Caesarean section.
* Psychiatric problems which, in the investigator's opinion, are severe enough to interfere with the trial results.
* Participation in another clinical trial within 30 days prior to screening.
* Evidence or suspicion that the subject might not comply with the study directives and/or that she is not reliable or trustworthy.
* Evidence or suspicion that the subject is not willing or unable to understand the information given to her as part of the informed consent, in particular regarding the risks and discomfort to which she would agree to be exposed.
* Previous participation in this clinical study.
* Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
* Subjects who are imprisoned or are lawfully kept in an institution.
* Employees or direct relatives of an employee of the CRO, the study center or Merz Pharmaceuticals.
Electronic Distraction for ICU Patients

This is a feasibility study of electronic devices in order to reduce neuro-psychological disorders and suffering in intensive care unit (ICU) patients. A first step study is necessary to define which device is effective and safe to reduce symptom intensities, among music therapy, virtual reality with real pictures, virtual reality with artificial pictures, and common devices (radio or television). If some devices are effective to reduce patients' symptoms, a second step will be to implement and assess the impact of these tools in a multicenter trial.

Quality of life following intensive care unit discharge is more and more anticipated during the ICU stay. Psychological trauma during ICU stay, related to medical management, can be very deleterious at short and long term, inducing psychological troubles as post-traumatic stress disorder and delaying the return to a normal social and professional life. For this reason, managing patients' distress is particularly important in the intensive care setting. There has been an increasing number of new technologies for the distraction of patients in different settings. a Today, a large amount of electronic distraction is available. TV and radio are available in each ICU, music therapy has already been studied and it is currently used in some ICUs. Virtual reality (VR) is used to improve attention and memory in stroke patients. Furthermore, VR seems to decrease stress post trauma disorders and phobia, as well as pain and anxiety during surgical procedures and physiotherapy. Our first step study will help us to determine which electronic distraction has the most effect on the top five discomfort symptoms frequently observed in ICU: pain, anxiety dyspnea, thirst and sleep privation.

Eligibility Criteria:
Inclusion Criteria:

* patient admitted in intensive care unit,
* adult,
* French speaking,
* awake (RASS ≥ -1),
* not delirious (CAM-ICU negative),

Exclusion Criteria:

* patient refusal
* psychosis or preexisting cognitive dysfunction
* cerebral injury,
* hygiene/microbiological harm,
* pregnancy,
* decision of withdrawal of care
Abdominal Aortic Aneurysm Screening Before Coronary Artery Bypass Surgery

Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. It has been reported that AAA is more prevalent in patients undergoing coronary artery bypass grafting (CABG). Despite all the evidence, current guidelines do not recommend routine screening for AAA before CABG. Syntax score shows anatomical significance of CAD and is associated with the degree of atherosclerotic load. The investigators aim to investigate if there were any differences regarding AAA prevalence in high-SYNTAX patients versus intermediate/low-SYNTAX patients.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary artery bypass graft surgery
* Age \>18 years

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Breastfeeding
* Emergency surgery