cyrilzakka/clinical-trials huggingface dataset:
Repeated GON Injections in CCH

Background:

- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.

Objectives:

- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.

Eligibility:

- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.

Design:

- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, the effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment.

Hypothesis: Repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 70 years
* Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)
* Ictal pain must be always at the same side
* ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period
* On a stable regimen of cluster headache prophylactics for \>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period

Exclusion Criteria:

* Contra-indication against, or current use of, corticosteroids
* Occipital nerve stimulation (ONS)
* Use of anticoagulation medication or a known bleeding disorder
* Inability to use an electronic diary to monitor individual attacks and other items
* Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache
* Current use of prophylactic medication for other headaches
* Pregnancy
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension

This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

This was an international, multicenter, open-label, long term extension study to evaluate the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at Baseline) with Tourette Syndrome. Participants who completed the Phase 2b, randomized, double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol deviations, and who met all the inclusion/exclusion criteria for this study were eligible to participate in this study. All participants were titrated to a target dose of 2 mg/kg/day as participants rolled over from the Phase 2b double-blind efficacy and safety study were tapered off study drug to maintain the blind from that study. Participants were to complete study visits every month for 1 year. Follow-up visits were conducted 7 and 14 days after the last dose of the study drug and a follow-up phone call was conducted 30 days after the last dose of study drug

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Exclusion Criteria:

* Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder).
* Unstable medical illness or clinically significant lab abnormalities.
* Risk of suicide.
* Pregnant or lactating women.
* Moderate to severe renal insufficiency.
* Positive urine drug screen.
* Certain medications that would lead to drug interactions.
Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* patient willing to sign an Investigational Review Board(IRB) approved written informed consent document
* patient age: 18 years -75years
* patient must have histologically confirmed solid tumor
* patient must have uncurable and unresectable solid tumor of advanced stages
* patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* patient must have a life expectancy at least 12 weeks
* patient must have at least one lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
* patient must have progress or recurrence after at least one chemotherapy regimen for advanced stage
* patient must have adequate marrow,hepatic and renal function: defined as ANC≥2.0 × 109/L，PLT ≥10 ×109/dL, Hb ≥ 9g/dL;GOT/GPT≤2.5×ULN；Toltle bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN or Creatinine clearance≥40ml/min(according to Cockcroft-Gault；
* patient must have the left ventricular ejection fraction (LVEF)≥50% confirmed by ultrasonic heart scanning
* women must have the negative pregnancy test; women and men must agree to use adequate contraception

Exclusion Criteria:

* patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study
* patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia)
* patient must non have uncontrolled cerebral metastases
* patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study
* Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years
* patient must non have any serious illness including, but not limited to hepatic, renal, respiratory and uncontrolled diabetes mellitus
* patient must non have psychiatric illness/social situations that would limit compliance with study requirements.
* patient must non have active or uncontrolled infection including, but not limited to tuberculosis,HIV,HBV, HCV
* Patient must non be receiving any other antitumor agent
* patient must non be pregnant and/or breastfeeding
* patient must non be receiving protease inhibitors,inhibitors of CYP3A4,antifungal agents and inducing agent of CYP3A4
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)

This study will evaluate the test-retest repeatability of lactate and other metabolites measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients radiographically diagnosed with glioma.

These measurements will test whether the concentration of lactate in tumor will be higher than the concentration of lactate in normal tissue of the same patient.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher which is \> 3cm in diameter based on radiographic examination
* Patients about to receive biopsy or resection of newly diagnosed glioma

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI): e.g. cardiac pacemaker, metallic implants, known contrast allergy, and pregnancy
* Impaired renal function
* Current or previous chemotherapy, radiation, or other tumor treatment excluding steroids
* Tumor location extra-cerebral, temporal, or in close proximity to frontal sinus
Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back

The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement.

The hypothesis is that there will be no difference between the two types of treatment.

Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-64 years of age
* Fluent in English
* With non-specific low back pain
* No lumbar manipulation within the prior 24 hours
* Not involved in strenuous back exercise on the day preceding the study
* Have not taken pain medication for two days prior to the study

Exclusion Criteria:

* Absolute contraindications to manipulation
* Specific causes for the low back pain
* Involved in or pending litigation for low back pain
* Lumbar related leg pain
The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women

This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse.

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. Rates of PTSD are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression, substance abuse, and poor overall health. In turn, these issues lead to high rates of utilization of mental health services. Unfortunately, there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings. Trauma Recovery and Empowerment Model (TREM) is a group-based intervention that addresses PTSD and other closely related consequences of sexual and physical abuse among women with severe mental disorders. This study will determine the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental disorders who have experienced sexual or physical abuse.

Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months. Usual care will include medication, case management, and therapy administered by a primary clinician. Participants assigned to usual care will report to the study site at least once a week, or as often as necessary. Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary. In addition, TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame. PTSD symptom severity, trauma beliefs, depressive symptoms, substance use, and mental health service utilization will be measured at Months 6, 12, and 18 for all participants.

Eligibility Criteria:
Inclusion Criteria:

* History of physical and/or sexual abuse
* Diagnosis of a severe mental disorder
* Diagnosis of PTSD with a symptom severity score of 21 or higher

Exclusion Criteria:

* Severe developmental disabilities or organic brain damage
Partnership in Medication Management (PIMM) in Patients With Mood Disorders

Investigators are doing this study to examine if a new personalized education program for patients with mood disorders (depression and bipolar disorders) will help them take their medications as prescribed by doctors. Investigators will teach patients about how, when and why it is important for them to take their medications as prescribed. Also, investigators will ask patients why they do not take medications as prescribed. Furthermore, investigators will examine whether our education program might save money if it prevents problems related to not taking medication.

The efficacy of anti-depressants or lithium reported in clinical trials differs from clinical experience. Various factors such as non-adherence to treatment and poor tolerability to medications have been related to treatment non-response or treatment failure in mood disorders (major depressive disorder and bipolar disorder). Premature discontinuation of treatment for mood disorders is common. The long treatments, the patients' beliefs about medications, the lack of knowledge about the medication/treatment purpose, benefits, dosage, and side effects and the relationship between patient and healthcare providers affect treatment continuation.

Investigators are proposing a sequential explanatory mixed methods study to investigate a novel program for medication training in persons with mood disorders. The ultimate purpose of the program is to improve medication adherence in these persons. The primary component of the present study will be quantitative, i.e., a randomized controlled trial with 12 months of follow-up to examine the effect of one-on-one medication training, including the use of a checklist system, on medication adherence in patients with mood disorders. The training program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications. To the best of the investigators' knowledge, no research has comprehensively examined whether one-on-one medication training, as described above, may improve medication adherence in patients with mood disorders.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the inpatient clinic of the Mood Disorders Program, St. Joseph's Healthcare Hamilton
* with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
* able to speak, read, and understand English.

Exclusion Criteria:

* cut off score on Montreal Cognitive Assessment (MOCA; clinical judgement)
* significant suicidal or homicidal risk
* a medical condition/treatment known to affect the brain
* acquired brain injury.
Comparison of the Predictions of ETTcP With Pilot Balloon Palpation Among Anaesthesia Residents in Different Years

In routine practice, pressure is often attempted to be adjusted by palpation of the cuff pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation of the reliability of the palpation method, which is widely used in cuff pressure measurement in the absence of a manometer, with clinical experience. Our recommendation is to use an accessible manometer if available.

After the patients were premedicated with an appropriate dose of midazolam, anesthesia was induced with propofol, fentanyl and rocuronium. Endotracheal intubation was performed after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex. We used 7.5 and 8.0 sizes of sterile ETTs are made of polyvinyl chloride and have a high-volume low-pressure cuffed design that conforms to the shape of the trachea. ETTs for female and male patients and before intubation Tracheal tubes (Tyco Healthcare©, Wollerau Switzerland) cuffs were tested for leakage. The researchers were divided into two groups of 20, with anaesthesia residents (anesthesia experience between 1 months and 1 year, Group J) and those with more than 4 years (Group S). The ETT was placed using the conventional intubation technique with a Macintosh laryngoscope after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex.. It was asked to swell with air up to cmH2O and a 10 ml injector was used for this. Then Direct pressure measurement was achieved by a cuff manometer calibrated in cmH2O, which was attached to the ETT pilot balloon. The participant was not informed about the actual pressure of cuff. Then the air in the cuff was completely evacuated and the same procedure was repeated with the participant from the other group, the agreement of the two groups to the target value of 25 cmH2O was compared. The order of priority among the groups was randomized according to the closed-envelope method. Controlled positive pressure ventilation was started after the measurement.

In cases in which the cuff pressure was above 30 cmH2O or below 20 cmH2O, the pressure was regulated back to normal limits. During the study, patients were in a supine, head and neck neutral position. Anesthesia was maintained as in our routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergo elective operations with general anesthesia.
2. Ages between 18-75
3. ASA I-II-III patients

Exclusion Criteria:

1. Patient refusal
2. Patients with anticipated difficult airway

   - Tempero-mandibular and atlanto-occipitac joint limitation
3. Having ejection fraction less than 35%
4. Peroperative nasogastric tube inserted patients
5. Patients with a history of sore throat, hoarseness, difficulty swallowing before the operation
Relationships Among Sedentary Behaviors and Other Factors

Due to the increasing sedentary behaviors in older adults, it is important to understand the factors related to sedentary behaviors. Although systematic reviews have identified sociodemographic and environmental factors related sedentary behaviors, no study on the relationships between interested and important activities and sedentary behaviors in older adults was found.

In this study, investigators aim to investigate the relationships among interested and important activities, sedentary behaviors, and sociodemographic factors in older adults living in the community. Investigators will recruit 30 sedentary older adults living in the community who are cognitively intact, have no physical limitations, and are medically stable. Participants will be assessed once using subjective and objective measures:

1) estimated energy expenditure levels for interested, important, and current activities, 2) time spent on sedentary activities, and 3) sociodemographic factors.

The results of this study will provide supporting evidence for the role of meaningful occupations to decrease sedentary behaviors. In addition, the results may show the relevant sociodemographic factors that occupational therapy practitioners need to be aware when encouraging active lifestyle for sedentary older adults in the community.


Eligibility Criteria:
Inclusion Criteria:

* age of 65 years or older
* intact cognition confirmed by the Montreal Cognitive Assessment Blind score 18 or greater
* self-report of no physical activity restrictions from the physician
* sedentary lifestyle confirmed by the Rapid Assessment Disuse Index score 26 or greater,
* living 30 miles from the College of Allied Health Sciences at East Carolina University

Exclusion Criteria:

* An acute or terminal illness
* a myocardial infarction in the past 6 months
* unstable cardiovascular or metabolic disease
* neuromusculoskeletal disorders severely disrupting voluntary movement
* limb amputation
* upper or lower extremity fracture in the past 3 months
* current symptomatic hernias or hemorrhoids
* cognitive impairment
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)

Cognition is one of the core symptoms of schizophrenia. This study is a head-to-head trial between olanzapine and sertindole with cognition as primary outcome. The design is a 12-week double-blinded randomized controlled flexible dose study.


Eligibility Criteria:
Inclusion Criteria:

* AnICD-10 schizophrenia diagnosis F20.0-F20.9.
* Contraception.
* A negative pregnancy test for women.
* No known allergy to any of the substances in the study medication
* Baseline QTc \< 450 milliseconds for men and \< 470 milliseconds for women
* S-potassium and s-magnesium within normal reference range.
* Suboptimally treated on current antipsychotic medication
* Stable dosage of antidepressants and mood stabilizers one month before the inclusion
* Signed informed consent and power of attorney

Exclusion Criteria:

* Withdrawal of consent
* QTc prolongation \>500 milliseconds during the study
* Patients with known clinical important cardiovascular disease
* Significant substance abuse
* Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine.
* Calgary Depression Scale score ≥ 7
* Treatment that interferes with the metabolism of sertindole or olanzapine,
* Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing
* Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period
* Treatment with an anticholinergic after the first three weeks of the study
* Somatic illness, as judged by investigator, interfering with cognition
* Known risk of narrow angle glaucoma
* Treatment with electroconvulsive therapy (ECT) the last three months before inclusion, or treatment with ECT in the study period
* Treatment with clozapine or depot antipsychotics before inclusion