cyrilzakka/clinical-trials huggingface dataset:
Comparison of Electrotherapies for Chronic Low Back Pain

The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.

H-Wave® Device Stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical participants enrolled (n=38 per arm) of with the same number of visits and investigator contact time.

Eligible participants will be allocated through computerized randomization utilizing a stratified permuted-block randomization employing random block sizes. Allocation is concealed. Participants and assessors will be blinded. Participants will not be told what types of electrotherapy devices are being studied, only that there are different types, and that they may be randomized to receive a sham device.

Patients will be instructed on the use of the device they received to perform daily home therapy. Subjects will be assessed at week 1, 4, 8 and 12 for the primary and secondary outcomes measures. Compliance to treatment will be measured through an electronic meter on each of the devices, as well as by patient diary. Patients will be allowed to receive usual care from their own health care provider, with the exception of invasive procedures or surgery. Results will be analyzed by intention to treat methods.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Low Back Pain of at least 3 months duration
* ages 18-65
* Current VAS Pain Rating of 5 on 10 point scale
* No pain below the knee
* 75% of pain located in low back or buttock pain rather than lower extremity pain
* Proficient in English
* Able to complete and tolerate treatment for the study period.

Exclusion Criteria:

* Prior home use of H-Wave Device or TENS.
* Prior history of spinal fusion or failed spinal surgery syndrome.
* Laminectomy, laminotomy or discectomy within 12 months of enrollment.
* Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
* Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
* Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).
* Patients currently or who become pregnant will be excluded.
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
2. Signed informed consent for participating in the extension study.

Exclusion Criteria:

1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.

The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-75
* First kidney transplant from a living or deceased donor
* Receiving CNI and MPA
* Able to tolerate full dose MPA
* Calculated glomerular filtration rate \>=30ml/min by Cockcroft-Gault equation
* Able to tolerate renal graft biopsies
* Provided written, informed consent
* Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first Simulect administration

Exclusion Criteria:

* Known hypersensitivity to Simulect
* Current preformed PRA\>10%
* Multi organ or second kidney transplant
* Use of any investigational immunosuppressive drug within 1 month of inclusion
* Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
* Known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
* HBV, HCV, or HIV positive patients
* Current severe infection
* Receiving an organ from an extended criteria donor per United Network for Organ Sharing (UNOS) guidelines
* Dialysis dependent one month post transplant
* Live too far away from the transplant center for adequate follow up
Effective Dose of Statin Post PCI

In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded

In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups

Eligibility Criteria:
Inclusion Criteria:

* all patients who have undergone PCI due to chronic stable angina

Exclusion Criteria:

* Patients with acute coronary syndrome
* Primary LDL\>190 mg/DL
* Patients who developed statin-induced myopathy or rhabdomyolysis
* Persistent increase in hepatic enzyme levels or hepatic failure
* Pregnancy and breast feeding
* Statin hypersensitivity
* Patients with history of multiple atherosclerotic events
* Patients who received high intensity statin before the study enrollment.
Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain

Randomized control trial that to comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Primary outcome : to measure pain score after drug is given

objective; To comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Population : gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain and had experienced of breakthrough pain cancer in Rajavithi hospital sample size : 20 person/group Method ; Randomized control trial , Prospective Intervention : group A : injectable fentanyl in sublingual , group B : oral morphine syrup Primary outcome : to measure pain score after drug is given at 5, 15, 30, 45, 60 and 120 min secondary outcome : to record side effect of drug is given at 5, 15, 30, 45, 60 and 120 min Statistical method

* Categorical data = Chi-square test or Fishers' exact test
* Continuous data : comparison with Student t-test in normal deviation data and Man-Whitney U- test in abnormal deviation data • Analytical data with Pearson's correlation, Linear regression or Binary Logistic regression, Repeated Measures ANOVA with OR (95%CI) and p-value \<0.05

Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain

Exclusion Criteria:

* allergy in fentanyl or morphine
* abnormal cognitive function patient
Identification for the Treatment of Complex Arrhythmias

The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Signed the Patient Informed Consent Form (ICF)
3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of

   * Persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).
   * Drug-resistant Atrial Fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
   * Persistent AF despite prior conventional ablation.
4. Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
5. In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

1. Paroxysmal Atrial Fibrillation
2. Continuous AF \> 12 months (1-Year) (Longstanding Persistent AF)
3. Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) \> 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure.
4. A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease.
5. Left atrial size \>55 mm (echocardiography, parasternal long axis view).
6. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
7. Structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.
8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor), significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.
9. Enrollment in an experimental study evaluating another device or drug under investigation.
10. Prosthetic valve
11. Presence of intramural thrombus, tumor or other abnormality / condition that precludes vascular access, catheter introduction or manipulation.
12. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.
13. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use.
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection

The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic genotype 1-4 HCV infection
* For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Presence of cirrhosis
* Prior exposure to approved or experimental HCV Protease Inhibitors
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.

Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients age older than 18 years (including 18 years old);
* Diagnosis of adenocarcinoma of the stomach
* The clinic stage is ≥T2 and any N stage
* Patient had curative surgical resection, including proximal, distal, or total gastrectomy

Exclusion Criteria:

* Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
* Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)
* Early gastric cancer.
A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.

Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent.

Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement.

End of study will be defined as completion of the week 24 visit or premature withdrawal visit

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
2. Male or female preterm infants with a birth weight of less than 1500 g
3. Bilateral ROP with 1 of the following retinal findings in each eye:

   * Zone I, stage 1+, 2+, 3 or 3+ disease, or
   * Zone II, stage 3+ disease, or
   * A-ROP

Exclusion Criteria:

1. Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
2. Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
3. Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
4. Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
5. Participants who have contraindications according to locally approved ranibizumab label
Teaching Young Children Swim Survival Skills

This study is designed to evaluate whether commercially-available swim self-rescue schools are effective to teach children ages 12-23 months to stay safely alive floating in the water (or grasping the pool's edge) without adult intervention. The investigators will measure children's water self-rescue skills at baseline and then they will engage in commercially-available training over the course of several weeks. The investigators will then measure their skills again. Assessments will be conducted using a standardized protocol with a certified lifeguard present. Parents will also complete a short survey concerning child and family demographics and child and family swim and lifeguard training experience.


Eligibility Criteria:
Inclusion Criteria:

* child ages 12-23 months
* enrolled in self-rescue course at participating swim facility

Exclusion Criteria:

* medical conditions counter-indicating training in water
* previous experience in self-rescue swim courses
Stellate Ganglion Block in Beating Heart Surgery

studies suggest that off-pump coronary artery bypass surgery is associated with improved outcomes when compared to on-pump coronary artery bypass. many studies have shown that off-pump coronary bypass surgery reduces patient morbidity and mortality.

manipulation of the coronary arteries during cardiac surgery can stimulate the adjacent post-ganglionic sympathetic fibers and mimic stellate ganglion stimulation ,stellate ganglion block (SGB) can interrupt this reflex by decreasing the efferent cervical sympathetic outflows.

when adopting off-pump surgery , the cardiac surgery team must adopt new techniques to handle a beating heart and the variations in hemodynamics that can occur when performing this type of procedure the incidence rate of cardiac arrhythmia occurring during and after surgery is one of the major complication in open heart surgery. in addition , intraoperative hemodynamic disorders, caused by changes in plasma levels of epinephrine and norepinephrine after surgical stimulation , are some of challenges for patients undergoing off-pump coronary artery bypass surgery. hemodynamic disruption leads to myocardial ischemia, resulting in increased incidence of cardiovascular events and mortality.

stellate ganglion is formed by the fusion of inferior cervical and first thoracic sympathetic ganglia and is located behind the subclavian artery and anterior to the first rib. the inferior cervical cardiac nerves arise from the medial aspect of the stellate ganglia and provide the cardio-accelerator nerve fibers to the cardiac plexus. stellate ganglion stimulation augments peak systolic pressure, and the enhanced myocardial contractility is secondary to stimulation by postganglionic nerve fibers which traverse from stellate ganglion down the great vessels and along the coronary arteries into the myocardium.the blockage of inferior cervical cardiac nerves is responsible for the bradycardia seen following SGB. SGB has been shown to prevent and control perioperative hypertension induced by increased sympathetic activity.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective off-pump coronary artery bypass grafting surgery
* patients with an ejection fraction of more than 50%
* creatinine level of less than 2.0 mg / 100 ml
* no evidence of heart failure
* no significant chronic obstructive lung disease
* age of less than 60 years

Exclusion Criteria:

* emergency surgery
* patients on thrombolytic therapy
* patients with coagulation disorders
* patients requiring heart lung machine
* patients with clinical contraindications to SGB ( including allergy to local anesthetic , carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies , and severe chronic obstructive pulmonary disease )
* patients with history of atrial fibrillation
Comparing the Effectiveness of Various Interventions on Improving Lumbar Proprioception

University students ages 18-45, with no recent history of back injury and no history of back surgery, were recruited. Participants completed proprioception testing consisting of a standing side bending and seated spinal flexion test. Participants performed each test once, then were blindfolded and asked to replicate the tests 10 times. After the initial proprioceptive testing, the participants were randomly split into four groups and performed a 10-minute intervention exercise, before repeating the proprioceptive tests for final measurements. The four groups included: graded motor imagery, mirror visual feedback, augmented biofeedback, and diaphragmatic breathing. Participants also completed a Physical Activity Enjoyment Scale to rate their enjoyment of their intervention task

-For the seated forward flexion test, the participants' C7 and S2 vertebrae were identified and used as markers. The participants were asked to bend forward until the tape measure increased 5 cm from the original distance between the C7 and S2 vertebrae. Similar to the seated flexion test, during the side-bending task, the participants were asked to side bend until the tip of their middle finger was 10 cm closer to the floor. The participants were asked to memorize that point in their mind; they were then blindfolded and asked to repeat the movement 10 times, trying to recreate the original position to the best of their ability.

Between initial and final measurements of proprioception, the participants were randomly assigned to one of the following four groups for interventions for a 10-minute training session:

* Graded Motor Imagery Group: Participants were shown several flashcards with pictures of individuals' back oriented to either the flexed or side bent position. The participants stated which direction the image depicted and visualized themselves making the movement identified in the picture.
* Mirror Visual Feedback Group:

Participants viewed themselves in a mirror while performing flexion and side bending movements.

-Augmented Biofeedback Group: Participants used an augmented musculoskeletal feedback system smartphone application app and small sensors with Bluetooth technology to translate the movement of the participant into an avatar on the game.

-Diaphragmatic Breathing Group: Participants were told to sit on a chair with their back straight and feet flat on the floor with one hand on their chest and one hand on their stomach. They performed diaphragmatic breathing in a slow 4 second box method: breathing in for 4 seconds, holding for 4 seconds, breathing out for 4 seconds, and then hold for 4 seconds


Eligibility Criteria:
Inclusion Criteria:

* Healthy university students ages 18-35
* Must be able to perform low intensity exercise

Exclusion Criteria:

* Past medical history of back surgery
* Back pain within the past 6 months
* Musculoskeletal injury within the past 6 months