cyrilzakka/clinical-trials huggingface dataset:
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary

Cancer that has spread to the brain, or brain metastasis, is difficult to treat. Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the laboratory. This medicine has been used in the past to treat pain. But, in this study, it will be used to prevent new brain metastasis. This is the first time that meclofenamate will be used in patients with brain metastasis.

This is a pilot study which means that the purpose of this study is to determine if a larger clinical trial of meclofenamate is possible in patients with brain metastasis. This study also aims to find out what effects, good and/or bad meclofenamate has on the patient and the cancer that has spread to the brain. The investigators also want to learn more about potential effects that this drug may have in the digestive system.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* KPS ≥ 60
* At least one recurrent or progressive brain metastasis (es) from any solid primary tumor that is visible on MRI as assessed by the patient's treating physician.
* Recurrence may occur after any treatment: recurrence after whole-brain radiation, stereotactic radiosurgery, surgical resection, systemic chemotherapy are all acceptable.
* There is no limit on the number of brain metastases.
* Surgical resection or SRS to other recurrent lesions in the same patient are acceptable, provided one recurrent lesion remains untreated.
* Systemic disease must be well-controlled or NED in the opinion of the patient's primary oncologist.

Exclusion Criteria:

* Inability to get brain MRI +/- contrast
* Progressive systemic disease
* Known leptomeningeal metastases
* Primary Brain tumor
* Active Intracranial Hemorrhage
* Surgery less than two weeks before enrollment
* GI hemorrhage (active or in recent 6 months)
* Concurrent anti-platelet therapy
* Concurrent anti-coagulation therapy
* Active bleeding diathesis
* Platelet count ≤ 70,000/mm3
* International normalized ratio (INR) \> 1.6 and a Partial Thromboplastin Time (PTT) \> 40 seconds
* Serum Creatinine \>2 mg/dL OR CrCL \<30ml/min
* AST or ALT \> 200 U/L
* Hemoglobin \<8 g/dL
* Allergy to meclofenamate or other NSAID
* Inability to tolerate PO dosing
* Steroid dose increased in the most recent two weeks.
* Pregnancy
* Cardiac Arrhythmia requiring medical management and/or pacemaker.
* Known congestive heart failure requiring medical management
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure \[BP\] and pulse rate \[PR\]measurement, 12-lead electrocardiogram \[ECG\], and clinical safety laboratory tests
* If female and of childbearing potential (includes women who have been postmenopausal for \< 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;

Exclusion Criteria:

* Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score \>0);
* Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
Improving Sensitivity of Urine Cytology for Bladder Cancer

Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.


Eligibility Criteria:
Inclusion Criteria:

* Only adult male subjects who will not have surgery within a period of 2 weeks.
* Over the age of 18
* Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days

Exclusion Criteria:

* Cognitive impairment resulting in the inability to give informed consent
* Lack of spoken and written English resulting in the inability to give informed consent
* Presence of infectious disease
* Insulin dependent diabetes mellitus
* Endogenous osteosynthetical material implants
* Knee or hip prosthesis
* Pacemaker
* Epilepsy
* Musculo-skeletal disorders
* Weight in excess of 250 pounds
* Poor circulation
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events.

The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class.

By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated.

Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.


Eligibility Criteria:
Inclusion Criteria:

1. CRT-P/CRT-D patients with a feasible device for home monitoring
2. ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring
3. SR/AFib
4. Transmission performance \>80% in the first 2 weeks with new device
5. Informed consent

Exclusion Criteria:

1. Life expectancy\<1 year
2. Unable to transmit data
3. Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts
4. Expected non-compliance
5. Pregnancy
6. Known drug, alcohol abuse
7. Participation in other study or HM system concept
Liner Ablation Using Contact-force in Atrial Fibrillation

Linear ablation is frequently used in the procedure for persistent atrial fibrillation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.

The association between contact force values and successful linear block has not been revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing catheter.

Catheter ablation is currently accepted as a treatment option for symptomatic atrial fibrillation. Linear ablation is frequently used in the procedure for persistent atrial fibrillation. Multiple studies have shown benefit of linear ablation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.

Contact-force (CF) monitoring during procedure has recently been available. This technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (PV) isolation. It also helped to resolve the cause of PV reconnection. Some reports demonstrated that the association between reconnection and lower CF value.

Linear ablation has more variation to interrupt block and reconnection was more often than PV isolation. The association between CF values and successful linear block has not been revealed yet. In addition, the investigators aim to the effectiveness and safety of linear ablation by using CF sensing catheter.

Eligibility Criteria:
Inclusion Criteria:

* Patients age is18 years or greater
* Patients with persistent AF (AF episode lasting \> 7 days)
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
* Patients with recurrent or sustained arrhythmia after pulmonary vein isolation
* Patients undergoing a first-time ablation procedure for AF
* At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation
* Patients must be able and willing to provide written informed consent to participate in this investigation

Exclusion Criteria:

* Patients with long-standing persistent AF;
* Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years.
* Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
* Patients with AF felt to be secondary to an obvious reversible cause
* Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
* Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view)
* Moderate to severe valvular disease
* Reduced left ventricular function (ejection fraction \<40%)
* Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.
Ikervis for DED Due to GVHD Post Allo-HSCT

Dry eye disease (DED) is a common sequelae of graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Since Ikervis is reported to be a safe and efficacious treatment of DED associated with chronic GVHD, our study would like to study the efficacy of prophlactic Ikervis in preventing ocular GVHD development.

This is a prospective single arm interventional study.

The recruitment period will be over 12-18 months to enroll all suitable patients. The total duration of prophylaxis will be for 1 year. After completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated.

Forty subjects, undergoing allo-HSCT, will be recruited from the Singapore National Eye Centre upon referral from the Department of Hematology, Singapore General Hospital and followed up at least 5 times over a period of 12 months at the Singapore Eye Research Institute.

The images of the subject eyes will be recorded and stored electronically. These images (corneal fluorescein staining score, Lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. The Lipiview result is in video format.

Eligibility Criteria:
Inclusion Criteria:

* Age 13 and above
* Able to give informed consent

Exclusion Criteria:

* Presence of concurrent disease
* Unable to complete the follow up
Effects of Massage Versus Rest on Hormones

This study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin, and IL-1alpha). The investigators will also investigate whether, in the case of hormones changes, these influence social decision making.

Interested participants will have the experiment explained both verbally and in writing, and asked to give their informed consent in writing. After consent, the participants will be led to a private room for their first 30ml blood draw by a qualified phlebotomist. Participants will then have a second 30ml blood draw.

Eligibility Criteria:
Inclusion Criteria:

* Anyone English speaking and over the age of 18.

Exclusion Criteria:

* Minors and anyone who has used illicit drugs or alcohol in the last 24 hours.
A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)

The purpose of this study is to test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
* Patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
* Specific radiographic (X-ray) and MRI features must also be satisfied

Exclusion Criteria:

* Non-osteoarthritic causes of knee pain
* Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons
* Previous septic arthritis, tibial osteotomy or knee replacement in both knees
* Acute injury of knee ligaments or meniscus in past 2 years
* Knee arthroscopy in past 12 months
* Anticipated arthroscopy or surgery in next 18 months
* Use of intra-articular injections of hyaluronan (e.g. Hyalgan (TM), Synvisc (TM), Orthovisc (TM)) in past 6 months, or injections of glucocorticoids (e.g. Kenalog (TM), Aristospan (TM), Depo-Medrol (TM)) in past 3 months or anticipated knee injections during the study
* Glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study
* Other exclusion criteria apply-Please ask the study doctor for details
Vagus Nerve Stimulation for Autonomic Nervous System Activity

There are no generally accepted values for transcutaneous vagus nerve stimulation (taVSS application parameters (amplitude, frequency, intensity, duration, side) yet, therefore there are heterogeneous applications in studies. Although positive effects have been shown in different neurological, psychiatric and musculoskeletal diseases, taVSS treatment is not available yet. It is not clear which parameters are important in patient selection.In this study, it was aimed to investigate the change of taVSS effect in healthy individuals according to the level of autonomic nervous system activity before stimulation.

Healthy individuals between the ages of 18-45 without any disease will be included in the study. Male and female participants will be included in the study. Heart rate variability will be measured after participants are included in the study. A short 5-minute measurement will be made with the Polar H7 device, which can be measured with the belt attached to the chest. Heart Rate Variability measurement will be analyzed with the Kubios HRV program. Participants will be distributed to groups according to the SNS index and PNS index values obtained as a result of the Kubios analysis. According to the index scores obtained, the distribution of the groups will be made as \<-2, between -2 and +2 and \>2. Afterwards, 20 minutes of taVSS stimulation will be performed. As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz (Heartz), pulse width of 300 µs (microseconds) for 20 minutes, biphasic application will be given to each participant 2 times, with at least 48 hours between them.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between the ages of 18-45 will be included in the study.

Exclusion Criteria:

* Having an acute or chronic disease,
* Having previously undergone transcutaneous vagus nerve stimulation,
* Not smoking or using alcohol,
* Being in the post-menopausal stage in women,
* Being in the post-andropausal period in men,
* Being on constant medication,
* In menstruating women, stimulation and heart rate assessment will be postponed to the next week.
Holter of Movement in Patients with SMA Undergoing Treatment.

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed spinal muscular atrophy.
* Treatment by Spinraza ° or by risdiplam planned.
* Over 6 years old.
* Signed informed consent.

Exclusion Criteria:

- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy

The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.

The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Primary or secondary open-angle glaucoma
* High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
* Intolerance to medication.

Exclusion Criteria:

* Patients with previous glaucoma surgery
* Previous ocular surgery in the last 6 months
* Previous history of Laser trabeculoplasty in the last 12 months
* Moderate or severe diabetic retinopathy
* Active or recurrent eye disease (uveitis)
* Plateau iris
* Ocular neovascularization
* Aphakia
* Neovascular angle-closure glaucoma
* Previous history of intraocular or extraocular malignant neoplasm
* Pregnancy or lactation period, axial length\> 26mm and \<20mm
* Unwillingness for participating
Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.

Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.

The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).


Eligibility Criteria:
Inclusion Criteria:

* Surgical plan for total hip replacement
* Signing of consent form to participate in the study

Exclusion Criteria:

* Patient refusal
* BMI \> 40 kg/m2
* Surgical plan for revision of hip replacement
* Patient unable to quantify pain level
* Chronic kidney disease with a Glomerular Filtration Rate \< 50ml/min
* Previously medicated with opioids
* Patient unable to perform the surgery with spinal block
* Allergy to local anesthetics
* Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
* Allergy or contraindication to the use of morphine
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Secondary Objectives

* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.

Eligibility Criteria:
Main Inclusion Criteria:

* Has met diagnostic criteria for HSDD for at least 6 months
* Is willing and able to understand and comply with all study requirements
* Has a normal pelvic examination at screening

Main Exclusion Criteria:

* Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial
Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mg

The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the Eperisone HCl SR and Myonal in healthy Korean male adults.

Myonal: Eperisone Hydrochloride (muscle relaxant)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects age between 20 and 55 singed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs