cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease

KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.

Ketamine, a molecule mainly used as an analgesic in palliative care, turns out to be an excellent fast acting antidepressant. By acting as an NMDA receptor antagonist, its mechanism of action is complementary to classical and long acting antidepressants like Selective Serotonin Reuptake Inhibitors (SSRI). In particular, ketamine is able to boost synaptogenesis in only a few hours whereas long-term prescription of SSRI can stimulate neurogenesis.

The purpose of this study is to evaluate a new therapeutic strategy that could integrate ketamine in the same time than SSRI, to control depression symptoms faster and optimize patient's quality of life complementary to treatments of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient
* Supported by a functional palliative care unit
* Having a severe and progressive disease diagnosed
* Meet the criteria for major depressive disorder as defined by DSM in its version 5
* MADRS \> 19 ( moderate to severe)
* No antidepressant treatment or treatment introduced for more than four weeks
* In ability to receive clear information and give consent
* Beneficiary of a social security scheme

Exclusion Criteria:

* upper weight or equal to 100 kg
* ultimate phase (about 24 to 72 hours prior to death)
* unstable patient on cardiovascular diseases, including uncontrolled hypertension
* severe renal impairment (renal clearance less than 15 ml / min)
* psychiatric comorbidity: schizophrenia and schizoaffective disorder
* neurological comorbidity: recent cerebrovascular accident (Less than one month), Parkinson's disease, dementia
* treatment with ketamine received in the four weeks preceding the inclusion
* impaired judgment, cognitive or massive sensory impairment not allowing to receive clear information
* oral antidepressant treatment introduced less than four weeks ago
* dosage of oral antidepressant treatment upper than the marketing authorization for more than four weeks
* patient not covered by the social security system
* refusal to sign the consent
* minor patient or guardianship
* pregnant women (implementation of a urine pregnancy test before inclusion for women of childbearing age)
* lactating women
* intolerance or allergic reaction to ketamine or milnacipran.
* contraindications to the association of ketamine or milnacipran with the patient's usual treatment
PTSD Coach App Evaluation

PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major public health concern. Although effective treatments exist, affected individuals face many barriers to receiving traditional care. As smartphones are now carried by more than half of the U.S. population, they have the potential to overcome many of these barriers by delivering self-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy, feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample of trauma survivors with PTSD symptoms. After completing an eligibility phone screen or online screen, individuals who score a 35 or above on the PTSD Checklist (PCL) and consent will complete a baseline assessment and then be randomized to the PTSD Coach app condition or a waitlist control group. Additionally, those assigned to the PTSD Coach intervention will be instructed to download a research version of the app, called PTSD Explorer, that enables passive and objective monitoring of app use. Each individual will be reassessed at post-intervention (3 months) and follow-up (3 months later, or 6 months after completing baseline). The investigators predict that those using the PTSD Coach app will demonstrate a significant and sustained reduction in PTSD symptoms and increase in patient coping self-efficacy compared to the waitlist control group. The investigators will explore if there is a relationship between levels of engagement and PTSD symptom change.


Eligibility Criteria:
Inclusion Criteria:

1. Experienced or witnessed an extremely traumatic event that involved actual or threatened death or serious injury to you or someone else. Event must have occurred more than 1 month ago.
2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 35.
3. Have a smartphone or smart device that can download apps (iPhone, iPod touch, iPad, or android phone or tablet).
4. English is the primary language.
5. Available for the next 6 months to participate in the study and use smart device.

Exclusion Criteria:

1. Unable to give informed consent.
2. Is currently receiving mental health treatment.
3. Currently participating in other PTSD-related research studies
BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).


Eligibility Criteria:
Inclusion Criteria:

* Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
* Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
* No prior treatment with biologics
* Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening

Exclusion Criteria:

* History of inflammatory joint disease other than RA
* Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
* History of malignancy, carcinoma in situ, or high-grade dysplasia
* History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
* Clinically significant cardiac disease
* Treatment with prednisone \>10 mg orally daily
* Intra-articular steroid injection within 28 days before screening
* Clinically significant abnormality in hematology or blood chemistry values at screening
Genetic Epidemiology of Blood Pressure Intervention

To localize and identify new genes related to variation in blood pressure (BP) responses to a low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and the cold pressor test.

BACKGROUND:

Systemic hypertension is a complex disease determined by both genetic and environmental factors and is of significant public health interest. In addition, identifying genes that interact significantly with dietary sodium and potassium intake, or even the cold pressure test may enable clinicians to target life style modification for prevention and treatment of hypertension.

The study is conducted in response to a Request for Applications issued in October, 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood, and Sleep Disorders.

DESIGN NARRATIVE:

The study uses a family intervention study design. The investigators will recruit 750 sibships (n=1750 siblings) and their parents (n=1250) from 500 families, each family ascertained through a proband who has untreated high normal BP or stage-1 hypertension (systolic BP 130-160 mm Hg and diastolic BP 85-100 mm Hg) from rural China. They will collect baseline information on medical history, lifestyle risk factors, anthropometric measures, BP, and blood measures (renin activity, ACE, angiotensin II, natriuretic peptide, glucose, insulin, and lipids) in all participants, and dietary nutrient intake (three 24-hour recalls) and urinary sodium and potassium excretion (three 24-hour) in the siblings. They will conduct the following interventions in the siblings: a cold pressor test at baseline (day 2 or 3), a 1-week low sodium-feeding study (40 mmol sodium/day on days 4-10), a 1-week high sodium-feeding study (280 mmol sodium/day on days 11-17), and a 1-week oral potassium supplementation (90 mmol potassium/day on days 18-24). They will measure BP and 24-hour urinary sodium and potassium excretion during the last 3 days of each intervention period. They will also perform genotyping for genomewide linkage scans and for candidate genes in all siblings and their parents. BP responses to the interventions will be analyzed primarily as quantitative traits. The primary analyses include linkage analysis, transmission/disequilibrium test, and association analysis between genetic markers and BP responses to the interventions.

Eligibility Criteria:
No eligibility criteria
Utilisation of Angiox® in European Practice

The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe


Eligibility Criteria:
Inclusion Criteria:

* Eligible for, and receive treatment with Angiox®.
* Willing and able to provide written informed consent to the use of their data in accordance with relevant local Data Protection laws, policies and regulations

Exclusion Criteria:

* Participation in other interventional clinical research studies involving the evaluation of investigational drugs, including Angiox®, or devices at the time of enrolment.
* Patients not eligible for treatment for Angiox®.
Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients

This clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.


Eligibility Criteria:
Inclusion Criteria of participants:

Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene. Co-operative patients who show interest to participate in the study

Exclusion criteria of participants:

Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that might interfere with evaluation Patients who are allergic to any ingredients will be used in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity, VAS \<5 Patients with physical disabilities Pregnant or lactating women Other dental defects that causes pain. Allergy from any used materials or any allergic reaction during our clinical trial (The trial will be stopped at once and all the needed management against any allergic reaction will be done.)
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory epilepsy
* No Nasal conditions that would preclude the use of intranasal product

Exclusion Criteria:

* Subject with a clinical significant unstable medical abnormality
* Subject currently or regularly taking Clonazepam
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome

The purpose of this study is to test the efficacy and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment when tested by modern clinical standards and criteria.

Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies.

Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method.

This study is designed to evaluate the efficacy and safety of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old age group, male and female
* In accordance with the above Western medicine Rome III standards.
* In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
* Informed consent for treatment
* No change in appetite during treatments periods

Exclusion Criteria:

* Pregnant or lactation female patients, and Fertility male patients
* Present digestive system disease within current three months
* Take IBS medicines within ten days prior to treatment or during treatment
* Take depression medicine within ten days prior to treatment or during treatment
* Take pain reliever medicine within ten days prior to treatment or during treatment
* Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients
* If an emergency occurs; a physician terminates the treatment
* Cannot comply with the rules and cannot cooperate
Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life

The purpose of this study is to find out about the quality of life and health in a group of adults who had retinoblastoma when they were children. By quality of life, we mean how you are feeling about being satisfied with things in your life, including your physical health, your emotional health, and your ability to carry out daily activities. We hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with retinoblastoma at any age
* At least five years from completion of all retinoblastoma-directed therapy
* Able to provide informed consent and/or assent, if indicated
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.

Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation.

This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers.

Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previous AF ablation presenting with PMFL and recurrent AF
* Age: 18- 75 years
* Willingness and ability to give written informed consent
* Therapeutic INR for at least 4 weeks prior to the procedure

Exclusion Criteria:

* Reversible causes of AF such as pericarditis and hyperthyroidism
* Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation
* Enrollment in another clinical study
* Any other terminal illness
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals

Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.

The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.

The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Women who have delivered under epidural analgesia
* Women who have vaginal or caesarean delivery
* Women with the epidural catheter still in place

Exclusion Criteria:

-Women who experience fetal or maternal complications during delivery
Sedation and Guided Education for Depression Study

The goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. In this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic which might have antidepressant properties.

The main question this study aims to answer is: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?

Researchers will compare response-focused vs. diagnosis-focused education.

Qualifying participants will:

* Undergo a single intravenous infusion of propofol which will induce a temporary state of sedation
* Wear an EEG cap that records brain activity during sedation
* Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation
* Be asked to fill out surveys about their mood and other measures of well-being before and after treatment


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder of at least moderate severity
* Able to read, understand, and provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Certain substance use disorders
* Daily use of opioids and/or benzodiazepines
* History of psychosis, schizophrenia, or schizoaffective disorder
* Body mass index greater than 35 kg/m2
* Obstructive sleep apnea that is moderate and untreated, or severe
* Any gastrointestinal condition placing the patient at significant risk of aspiration
Study of Experience of High-frequency Repetitive Transcranial

Objective: To understand the personal experience of schizophrenia patients following repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental symptoms, thereby enhancing the overall understanding of TMS.

Method: The investigators selected eligible schizophrenia patients for fixed-parameter rTMS treatment. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.

The investigators recruited male subjects admitted to who met the criteria. They were divided into a control and a treatment group. A double-blind approach was adopted. The subjects were unaware of whether real/pseudo stimulation was applied, and the evaluators did not know the grouping specifics. All of the enrolled cases were tested for stimulation thresholds in the bilateral prefrontal cortex. The TMS treatment device was a Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil. The study group was administered real stimulation. The treatment parameters were as follows: frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. For the control group, a 60% motion threshold was set; the remaining parameters were consistent with the study group but with no stimulating energy output. The therapeutic instrument model, appearance, operation process, and sounds when effecting treatment were the same for both groups. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1) were aged 18-65 years;
* 2) fulfilled the diagnosis of International Classification of Diseases Edition 10 schizophrenia;
* 3) had been diagnosed with schizophrenia more than five years previously;
* 4) were in a stable condition;
* 5) whose medication remained unchanged during treatment;
* 6) who did not have a history of epilepsy (including drug-derived);
* 7) had no brain trauma or surgery history;
* 8) who accepted treatment voluntarily and provided signed informed consent for inclusion in the study

Exclusion Criteria:

* 1) showed contraindications to rTMS intervention;
* 2) had other neuropsychiatric disorders;
* 3) received non-convulsive electroshock treatment a month preceding the start of the study;
* 4) indicated an impulse for attacking actions and engaged in destructive and self-harming behavior;
* 5) experienced generalized or electricity-related delusionsof reference,influence, andpersecution.