cyrilzakka/clinical-trials huggingface dataset:
Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients

Primary objective: To estimate the frequency of adverse events, serious and non-serious in Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once daily within the study duration of approximately 6-8 weeks in a naturalistic clinical setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino patients within the study duration of approximately 6-8 weeks in a naturalistic clinical setting.


Eligibility Criteria:
Inclusion Criteria

* Are of Filipino race
* Are male or female outpatients at least 18 years of age
* Provide written consent to the release of their data after being informed of the study
* Are known diabetics and have been clinically diagnosed by the investigator to have Diabetic Peripheral Neuropathic Pain
* Are judged by the investigator to be reliable, and agree to keep appointments for clinic visits, complete tests and procedures as may be required by his/her attending physician in the course of routine clinical care
* Treated with duloxetine according to the approved Product Information as prescribed by the investigator in the routine care of the patient, without the concomitant conditions and medications specified therein as contraindicated

Exclusion criteria

* Are the investigators or their immediate families. Immediate family was defined as the investigator's spouse, parents, naturally or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible
* Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
* Are hypersensitive to duloxetine or any of its components
* Are pregnant and/or nursing mothers
* Have concomitant conditions contraindicated for duloxetine treatment, as described in the Product Information (e.g. liver disease resulting in hepatic impairment, severe renal impairment)
* Are concomitantly taking contraindicated medications, as described in the Product Information (e.g. fluvoxamine, ciprofloxacin)
NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \<15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly.

The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 4 years and \<15 years of age
* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame
* Able to walk independently without assistive devices
* Ability to complete the TTSTAND without assistance in \<20 seconds
* Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study.
* Other inclusion criteria may apply.

Exclusion Criteria:

* Has a body weight of \<20 kg at the time of informed consent (applies to participants screening for Part 1 only)
* Evidence of symptomatic cardiomyopathy
* Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug
* Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer
* Surgery within the 3 months prior to the first dose of study drug or planned during the study duration
* Previously treated in an interventional study of NS-089/NCNP-02
* Having taken any gene therapy or other exon-skipping oligonucleotide
* Other exclusion criteria may apply.
Blood Concentration in Lorazepam and Treatment in Adult Catatonia

Catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. It affects approximately 10% of acute psychiatric inpatients. According to the fifth edition of DSM-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. It can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders \[metabolic disturbances, viral infections (including HIV), typhoid fever, heat stroke, and autoimmune disease\].

Benzodiazepines, especially LORAZEPAM, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. This first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. Electroconvulsive therapy (ECT) is initiated on patients with catatonia who do not respond to benzodiazepines.

Interestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the UGT2B15 \* 2 allele slows it down).

The main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. Our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. Evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* catatonia according DSM-5

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject is pregnant at the time of the study
* Subject/legal guardian unwilling to participate in the study
Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma

This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed squamous cell or poorly differentiated or undifferentiated cancer of the head and neck (the primary sites include oral cavity, oropharynx, hypopharynx, larynx, nasal cavity and sinuses);
2. Clinical stage of III-IVb (AJCC 2018);
3. Surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy;
4. Measurable disease;
5. Eastern cooperative oncology group performance status (ECOG PS) score: 0-1;
6. Blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/L, platelets\> 80,000/mm3；Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal; Renal function: serum creatinine \<1.5 times the upper limit of normal;
7. Sign the informed consent.

Exclusion Criteria:

1. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
2. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
3. Has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
4. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
5. Patients undergoing therapy with other investigational agents;
6. Women who are pregnant or breastfeeding;
7. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
Regional Distribution of Ventilation in Patients With Chronic Heart Failure

Inspiratory muscle dysfunction is a reduction in the ability to generate pressure and force by the inspiratory muscles. This decrease in the strength of these muscles can be attributed to biochemical and histological changes. Some patients with CHF showed a reduction of maximal inspiratory pressure (MIP) and inspiratory muscle endurance, and such factors known to exercise limitation and deterioration in quality of life and worsens the prognosis of these patients. This study aims to evaluate the Regional pulmonary distribution volume and the influence of enclosures system thoracoabdominal in CHF patients with cardiomegaly associated with diaphragmatic weakness during quiet breathing and during exercise for inspiratory muscle and its correlation with functional data. The investigators evaluated a total of 31 individuals divided into two groups: CHF and control. In the control group, twelve volunteers participated with similar age, gender and body mass index in relation to the group of patients with CHF. The control group participants had an ejection fraction of left ventricle (EF)\> 50% without cardiac abnormalities of the cameras and MIP over 80% of predicted. To conduct the exercise to the inspiratory muscles (EMI) was used for IMT Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients with several pathologies such as CHF. The exercise time was 3 minutes. During this period, participants were encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and 16ipm. Opto-electronic plethysmography measures the volume changes of thoracoabdominal system by placing 89 markers formed by hemiesferas covered with retro-reflective paper, taking the place of each of these hemiesferas determined by anatomical landmarks on the anterior and posterior regions of the chest and abdomen. According to our study, a lower ventilation on diaphragmatic region would lead to an increased perception of dyspnea during submaximal exercise in this population. Moreover, the observed changes in the pattern of regional distribution of ventilation in CHF patients compared to healthy individuals can serve as a basis for prospective cohort studies using IMT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as CHF associated with cardiomegaly
* Class II and III (NYHA)
* Left ventricular minor 45% (method Teicholtz)
* Inspiratory muscle weakness (PiMáxima \<70% predicted)
* Duration of symptoms \> 1 year
* Body mass index (BMI) \< 35kg/m2
* Non-smokers or former smokers with a smoking history \< 10 pack-years

Exclusion Criteria:

* Patients with chronic heart failure who had unstable angina, myocardial infarction or heart surgery until three months before the survey
* Orthopedic diseases or respiratory comorbidities such as asthma and COPD
The Effect of Motivational Interviews

The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress.

There is no study in the literature on the effectiveness of motivational interviewing on being affected by infertility, self-efficacy and coping with stress. It is important for healthcare personnel to be easy to apply and short-term, to be aware of the effectiveness of the motivational interviewing technique, and to use this technique in communicating with the patient and changing behavior. Based on these, it was deemed necessary to examine the effect of motivational interviews for infertile women.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and over and have no problems communicating Those who have not previously or currently been diagnosed with a psychiatric disease Infertile women who volunteer will be included in the sample of the research

Exclusion Criteria:

* Pregnancy during the study, Having previously or currently participated in a motivational interviewing program, Those who want to leave the research, Not completing motivational interviewing sessions, Infertile women with any deficiencies or errors in any of the forms from which the data are obtained will be excluded from the sample.
Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment

Our study is a survey of the current management of patients suffering from spondylodiscitis.

Our main objective was to describe the use of rigid corsets to immobilise patients with spondylodiscitis in hospital, by asking doctors about their practices.

The secondary objectives are :

* To describe the use of rigid corsets to immobilise patients suffering from spondylodiscitis in hospital by asking paramedical staff about the way in which medical prescriptions were implemented and patients about their compliance.
* To measure the rate of satisfaction and understanding of patients treated with a corset.
* To detail the different ways in which doctors and paramedical staff manage patients hospitalised for spondylodiscitis, depending on their age, training, speciality and the department in which they work.

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Patients aged over 18,
* Patients hospitalised at Clermont-Ferrand University Hospital with infectious spondylodiscitis,
* Patient willing to be interviewed.

For care workers:

- Doctors, nurses or care assistants involved in the care of patients hospitalised with spondylodiscitis.

Exclusion Criteria:

For patients :

* Minor patients,
* Patients wearing a corset for a non-infectious spinal pathology,
* Patient refusing to take part in the study.

For care workers:

- Doctor, nurse or nursing auxiliary refusing to take part in the study.
Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder

This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.

The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. The safety of FK949E in the population is also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients considered to be able to understand and follow subject requirements, as judged by the investigator/sub-investigator.
* Patients diagnosed with major depressive disorder according to the DSM-IV-TR by means of M.I.N.I.
* BMI: 17.6 (inclusive) to 26.4 (exclusive).

Exclusion Criteria:

* Current or past history of DSM-IV-TR Axis I disorder, except major depressive disorder, within the past 6 months before informed consent.
* Concurrent DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status.
* Current or past history of dependence of substances (other than caffeine and nicotine) or history of abuse or dependence of alcohol.
* Unable to suspend treatment with inducers or inhibitors of the drug-metabolizing enzyme, cytochrome P450 3A4 (CYP3A4), for 14 days before the screening assessment and throughout the study.
* Patients who could not use an appropriate contraception (condoms) during the study. Patients who were pregnant or lactating.
* Patients (carriers) with documented or suspected renal failure, hepatic failure, serious cardiac disease,

hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS).

* Patients receiving treatment for hypertension, or patients with concurrent hypertension or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator/sub-investigator.
* Patients with concurrent hypotension (criterion for hypotension: a systolic blood pressure of less than 100 mmHg), or orthostatic hypotension
* Patients with a mean QTcF interval of ≥450 ms on a 12-lead ECG at the screening assessment
* Patients with the risk of torsades de pointe (e.g., those with a history of QT prolongation, those with familial long QT syndrome).
* Concurrent malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug.
* Concurrent malignancy or history of cured malignancy within 5 years
* Current or past history of cerebrovascular disease or transient ischemic attack (TIA).
* Received electroconvulsive therapy within 90 days before the screening assessment
Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Researchers are trying to find out more about the side effects of fremanezumab when treating patients with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) for migraine headaches.

Subjects will receive 4 to 20 weeks of placebo injections followed by 12 weeks of monthly administered fremanezumab by subcutaneous injection (225 mg split four weeks apart for 12 weeks). Following completion of the 12 weeks of therapy, the participant will return to placebo for the washout period. Both the patient and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Eligibility Criteria:
Inclusion Criteria

* Age 18 to 70 years old
* English speaking
* Diagnosis of CADASIL confirmed by presence of a pathogenic NOTCH3 gene mutation
* Diagnosis of migraine for at least 12 months and diagnosis of chronic migraine for at least 28 days according to the International Classification of Headache Disorders
* MIDAS score of \>10 points
* Ability to provide written informed consent

Exclusion Criteria

* History of ischemic stroke within 4 weeks of screening assessment
* Screening blood pressure \>150 mm Hg
* Use of onabotulinum toxin A 4 months prior to trial or other injectable/stimulatory/magnetic method of headache control
* Use of opiates or barbiturates 4 days prior to trial
* Patients with competing intracerebral pathology (e.g. history of intracerebral hemorrhage, multiple sclerosis)
* NYHA Class III or IV congestive heart failure
* History of myocardial infarction
* History of coronary bypass surgery or coronary stenting
* Pregnancy or breastfeeding
* Contraindication to undergoing brain MRI per standard clinical practice guidelines
* Vulnerable populations, including incarcerated inmates, dementia, and inability to provide consent
Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation

Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. CAV has been associated with a variety of traditional risk factors for atherosclerosis; however, immune mediated injury from development of de-novo donor-specific antibodies after transplantation also likely plays an important role. Similar to the progression of traditional atherosclerosis, it is likely that endothelial dysfunction is the precursor to the development of intimal thickening and CAV.

The investigators hypothesize that coronary allograft vasculopathy after heart transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial dysfunction, which in turn is at least partly mediated by donor specific antibodies.

The investigators are proposing a prospective study in humans to test the above hypothesis and further mechanistically understand how CAV progresses. In this study the investigators will test for coronary endothelial function by infusing acetylcholine into the coronary artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare findings in patients with and without donor specific antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 1 year post heart transplantation
* Subjects will include both male and females
* Be at least 18 years of age

Exclusion Criteria:

* Known coronary artery disease after transplantation
* Evidence of strong or moderate antibodies already present at the time of the transplant
* Severe renal dysfunction defined as creatinine clearance of \<30 or on hemodialysis.
* 3 or more episodes of acute cellular rejection
* Females who are pregnant
* Patients requiring endomyocardial biopsy at the time of catheterization
* Patients unable to tolerate heparin or systemic anticoagulation
* History of multi-organ transplant
* Patients unable to give consent