cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:

  * Screening UEMS score must be ≤16 points on each side.
  * AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side.
  * AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side.
* American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.
* Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.
* Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.

Exclusion Criteria:

* Participation in any other clinical study for acute SCI without approval by the sponsor.
* Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
* One or more upper extremity muscle groups untestable during screening ISNCSCI examination.
* Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
* Females who are breastfeeding or have a positive serum pregnancy test.
* Body mass index (BMI) of ≥40 kg/m\^2 at screening.
* History of an adverse reaction to a fibrin sealant or its components.
* Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
* Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
* Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator.

Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients

Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic patients after treatment with SUs for 5 years, although SUs are widely used in type 2 diabetic patients. This study was designed to evaluate the effectiveness and safety of adding compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad glycemic control with the initial treatment of SUs.

Design of this clinical trial was multicenter, randomized, double-blind and placebo parallel controlled. Type 2 diabetic patients having bad glycemic control with the initial treatment of SUs were included. They were randomly divided into experiment group and control group, respectively taking compound preparation of pioglitazone and metformin (2mg/500mg) and placebo with identical shape immediately before a meal twice a day. Course of the treatment was 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients (WHO criterion, 1999)
* 19kg/m2 ≤ BMI ≤ 35kg/m2
* Subject with the initial treatment of SUs on the basis of controlling diet and sport; treatment lasting for no less than 3 months and stable dose for at least 1 month; HbA1c 7-11%
* No insulin therapy during 6 months before being selected
* Not involved in any drug test during 3 months before being selected
* No serious heart, liver or kidney diseases
* Must have effective contraception methods for women of child-bearing age
* Willing to being informed consent

Exclusion Criteria:

* Type 1 diabetes or other specific types of diabetes
* Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
* Uncooperative subject because of various reasons
* Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal
* Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
* Serious chronic gastrointestinal diseases
* Edema
* Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
* Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
* White blood count (WBC) \< 4.0×109/L or platelet count (PLT) \< 90×109/L，or definite anemia (Hb：\< 120g/L for male, \< 110g/L for female), or other hematological diseases
* Endocrine system diseases, such as hyperthyroidism and hypercortisolism
* Experimental drug allergy or frequent hypoglycemia
* Psychiatric disorders, drug or other substance abuse
* Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
* Stressful situations such as surgery, serious trauma and so on
* Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
* Combined use of drugs effecting glucose metabolism such as glucocorticoid
* Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Botulinum Toxin in the Treatment of Raynaud's

The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP.

In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another.

This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and anticoagulants. If the patient chooses to participate in the study, he/she will be randomly assigned to receive an injection with Botulinum toxin in either the left or right hand. The other hand will be injected with saline solution. Neither the patient nor the physician or research personnel seen in follow-up will know which hand is injected with Botulinum toxin.


Eligibility Criteria:
Inclusion Criteria:Adult (\>18 years) patients with severe RP of any etiology will be invited to participate. Inclusion criteria include a) history of digital infarcts or ulcerations, b) unresponsive to standard therapies, or c) impending potential for digital amputation. Patients on other standard therapies such as antiplatelet agents, vasodilators, and calcium channel blockers will be included. -

Exclusion Criteria:Pregnancy, mild disease, patients with myasthenia gravis, botulinum toxin allergy, and phobia of needles are exclusion criteria. Women of childbearing age will need to demonstrate a negative urine pregnancy test. Myasthenia gravis is excluded because underlying generalized weakness can be exacerbated, and local weakness at injection sites can occur more than otherwise expected.

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Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)

The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).

This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission to the ICU
* Intubation and duration of invasive mechanical ventilation \> 48 hours
* Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP)

Exclusion Criteria:

* Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy
* Organ donor
* Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times)
* Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices
* Patient and/or family opposition to participation
* Lack of affiliation with a social security system
Tanezumab In Osteoarthritis Of The Knee (2)

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

* Pregnancy or intent to become pregnant
* BMI greater than 39
* other severe pain, significant cardiac, neurologic or cardiac disease
The Feasibility of Florbetapir Quantitation

The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Readers have undergone Amyvid reader training
* Readers have minimal experience with quantitation of amyloid PET scans

Exclusion Criteria:

* Readers have previously been trained to quantitate amyloid PET scans
Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.

Eligibility Criteria:
Inclusion Criteria:

* The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
* The participant is willing and able to cooperate with all aspects of the protocol.
* The participant is willing and able to provide signed informed consent.

Exclusion Criteria:

• Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease
A Multi-center Study of Apixaban(APPROACH)

The aim of the study is to enroll approximately 200 cases from 10 research centers nationwide, completed left atrial appendage occlusion (LAAO) successfully, and give apixaban (5 mg bid) postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 85 years;
* understand the purpose of the trial, sign the informed consent form voluntarily
* successful surgery (no pericardial effusion, pericardial tamponade, or device displacement during operation; no pericardial effusion before discharge), meet COST standard during operation.
* In accordance with the indications for left atrial appendage occlusion: CHA2DS2-VAS2 score≥2 points and/or HAS-BLED score≥3 points
* unable or unwilling to take oral anticoagulants
* life expectancy≥1 year

Exclusion Criteria:

* History of previous cardiac surgery (valve disease, cardiomyopathy, severe coronary occlusion);
* Inability to tolerate trans-esophageal echocardiography;
* Preoperative trans-esophageal echocardiography suggests thrombus in left atrial appendage/left atrial;
* Patients with severe renal insufficiency (creatinine clearance rate\<15ml/min);
* Patients with liver disease accompanied by abnormal blood coagulation and clinically related bleeding risks;
* Clinically significant active bleeding;
* The baseline platelet count is severely reduced: PLT≤50\*10\^9/L;
* Severe cardiac insufficiency (preoperative transthoracic echocardiography indicated LVEF \<35%; uncontrolled heart failure (NYHA IV))
* Allergy or contraindication to anticoagulant drugs such as aspirin, clopidogrel, apixaban, etc .;
* Serious heart valve disease or other structural abnormalities need do elective surgical treatment; or severe coronary heart disease require limited-term intervention;
* Less than 45kg or more than 100kg.
* Take strong CYP3A4 and P-gp inhibitors (including pyrrole antifungal drugs, HIV protease inhibitors, etc.) for systemic treatment;
* Patients with other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.) need anticoagulation treatment;
* Unsuccessful surgery (serious pericardial tamponade, massive bleeding and other life-threatening complications occur within 3 days after left atrial appendage closure);
* Pregnancy or lactation;
* Participating in other uncompleted clinical trials;
* Investigator considers inappropriate subjects.
Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

In recent years, the finding of long-term deleterious effects of right ventricular pacing (RVP) has led to an ongoing search for alternative pacing sites such as His bundle stimulation. The depolarization of the ventricles through the His-Purkinje cardiac conduction system seems to represent an ideal physiological approach to ventricular pacing, capable of engaging the normal conduction pathways and determining synchronous ventricular activation. However, there are still no clinical studies that have evaluated the electromechanical functions of the left ventricle with His bundle pacing (HBP) identified after electroanatomical reconstruction with 3D mapping system. Investigators aimed to compare the electromechanical effects on left ventricle of HBP, compared to RVP stimulation and to spontaneous rhythm of each patient.

Patients with indication for permanent pacemaker implantation were included in the study. The stimulation lead was positioned at the level of the His bundle after complete electroanatomical reconstruction of the atrium and right ventricle with 3D mapping system; a second backup lead was eventually placed in the right ventricle. Within 24 hours after implantation, each patient underwent 12-lead ECG and a complete echocardiographic examination in the different pacing modalities (HBP, RVP and patient's spontaneous rhythm) focused on the evaluation of biventricular systo-diastolic function, speckle-tracking and myocardial work of the left ventricle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of class I or class IIa for permanent pacemaker implantation, in accordance with the guidelines of the European Society of Cardiology on cardiac pacing
* Age ≥ 18 years
* Written consent

Exclusion Criteria:

* Patients unable to express informed consent
* Pregnancy
* Severe mitro-aortic valve disease
* Left ventricular ejection fraction ≤ 35%
Efficacy of ArTiMist™ in Children

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.


Eligibility Criteria:
Inclusion Criteria:

1. The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
2. The patient is a child that weighs between 5 and 15 kg (kilogram)
3. The patient has falciparum malaria as evidenced by

   1. Thick or thin blood smears of \> 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided \>500 P Falciparum /mcl) and /or
   2. Positive RDT (rapid diagnostic test)for malaria
4. The patient has either

   1. severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
   2. the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

1. Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial.
2. Ability to tolerate oral therapy
3. Patient has received any treatment with an artemisinin or quinine in the last 24 hours
4. Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
5. Patient is allergic or intolerant to artemisinins.
Patient Driven Recovery With Nalmefene and Coaching

In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented drug counseling). The proposed pilot study will also be used to further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

The specific aims and hypotheses of the proposed study are as follows:

Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching for rehabilitation of detoxified opioid dependent individuals in Russia.

Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

Eligibility Criteria:
Inclusion Criteria:

* individuals who meet DSM IV criteria for opioid dependence, who use street methadone (the main, most frequently used street opioid in Saint Petersburg, Russia) by intravenous injections, who have a history of alcohol use disorder or high risk alcohol use, who successfully completed inpatient, medically supervised detoxification, who are seeking a rehabilitation treatment following detoxification, and who pass a naloxone challenge (indicating the current lack of physiological dependence on opioids)

Exclusion Criteria:

* current suicide or homicide risk; current psychotic disorder or major depression; inability to understand the consent form or assessments; pregnancy; acute medical conditions requiring medical treatment, co-occurring dependence/abuse of other drugs including alcohol, benzodiazepines, or amphetamine type stimulants (ATS)
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention

The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.

Patients will be recruited by consecutive non-probabilistic sampling at the Outpatient Mental Health Centre of Nou Barris in Barcelona and subsequently randomised into 2 groups, control and intervention. Presence and severity of insomnia will be assessed through the following measurement instruments: ISI for presence and severity, PSQI for sleep quality and EQ-5D for health-related quality of life. Patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up. Pre-post, 6-month and 9-month assessments will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia disorder (ISI scale)
* Schizophrenic disorder

Exclusion Criteria:

* Presence of severe psychopathological alteration
* Inability to understand the Spanish language or difficulties writing or reading