cyrilzakka/clinical-trials huggingface dataset:
Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older.
* Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).
* At least 1 measurable site of disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
* Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

* Prior treatment with VELCADE.
* Prior extended radiotherapy or chemotherapy for lymphoma
* More than 150 mg/m2 of prior doxorubicin
* Major surgery within 3 weeks of study.
* Peripheral neuropathy or neuralgia of Grade 2 or worse.
* Active CNS lymphoma
* Diagnosed or treated for a malignancy other than NHL, with some exceptions
* Pregnant or breast feeding
* Active systemic infection
* Documented of suspected human immunodeficiency virus (HIV)/AIDS
* Uncontrolled or severe cardiovascular disease
* Known allergies, hypersensitivity or intolerance to study drugs
* Serious medical condition that could interfere with study
* Concurrent treatment with another investigational agent
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old at the screening visit (Visit 1).
* Has a diagnosis of FECD at Visit 1.
* Meet all other inclusion criteria outlined in clinical study protocol.

Exclusion Criteria:

* Has a study eye with a history of cataract surgery within 90 days of Visit 1.
* Has a study eye with a history of any previous ocular surgery other than for cataract.
* Meet any other exclusion criteria outlined in clinical study protocol.
Multi-Center Clean Air Randomized Controlled Trial in COPD

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

The Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air) is a multi-center, prospective, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers with COPD over a 4-year period and follow participants at regular intervals for one year. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.

Eligibility Criteria:
Inclusion criteria

To be eligible, subjects must meet all these criteria:

1. Age ≥ 40 years.
2. Self-report of physician diagnosis of COPD.
3. Spirometry confirmed airway obstruction (post-bronchodilator spirometry of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \< 0.7) as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (6, 11)
4. Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption.
5. Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use.
6. COPD Assessment Test (CAT) score ≥ 10, Modified Medical Research Council dyspnea scale (mMRC) ≥ 2, or history of moderate or severe exacerbation in the past 12 months (as defined by history of receiving a course of systemic corticosteroids or antibiotics for respiratory problems; or visiting an emergency department or being hospitalized for a COPD exacerbation within the past 12 months.)

Exclusion criteria

To be eligible, subjects must not meet any one of these criteria:

1. Living in a location other than home (e.g., long-term care facility, nursing home)
2. Other chronic lung diseases, except asthma
3. Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice
4. Spends \>2 months per year in location other than home; or plans to change residence in the next 12 months
5. Pregnant or breastfeeding
6. Current air cleaner use in the home
7. Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
8. Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity
9. Participating in another interventional clinical trial
RAM-Based Virtual Reality Glasses and Adaptation, Satisfaction, Well-Being in the Elderly

The main purpose of this study is to determine the effect of Roy adaptation model-based virtual reality glasses application on adaptation difficulties, life satisfaction, and psychological well-being in the elderly using a randomized controlled experimental method.

The hypotheses of the study are:

H1: The Roy adaptation model-based virtual reality glasses application has an effect on adaptation difficulties in the elderly.

H2: The Roy adaptation model-based virtual reality glasses application has an effect on life satisfaction in the elderly.

H3: The Roy adaptation model-based virtual reality glasses application has an effect on psychological well-being in the elderly.

In the 21st century, advances in science and technology have led to demographic changes, resulting in an increase in the elderly population. In this process, developments in the field of health such as increased preventive health services and early diagnosis and treatment of diseases played an important role. Aging is a natural process and can be defined as a decrease in an individual's physical and spiritual functions and an increase in external dependency. Adapting the elderly to this period supports psychological well-being by increasing functionality and life satisfaction. The Roy Adaptation Model aims for nurses to meet the needs of individuals to adapt, and this model can also be applied to the elderly. With technological advances, innovations such as virtual reality are used in the field of health and help improve the quality of life of the elderly. In the literature, studies examining the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly are limited. This study aims to determine the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly and to lay the foundation for evidence-based research. The thesis is a pre-posttest randomized controlled study with experimental and control groups. In the thesis study, data were collected as pre-post test from the elderly living in nursing homes using the Personal Information Form, Adaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly, and Psychological Well-Being Scale in the Elderly.In the thesis study, the experimental group was shown educational videos and nature videos with VR SHINECON 360 degree virtual reality glasses, based on the Roy adaptation model adaptation areas titles (physiological needs, self-concept area, role function area, interdependence area) twice a week for four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 60 and over
* Residents of Kocaeli nursing home
* Those who score 25 and above in the Standardized Mini Mental Test

Exclusion Criteria:

* Not wanting to participate in the research voluntarily
* Those who score 24 or below on the Standardized Mini Mental Test
Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia

Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well.

Patients diagnosed with idiopathic trigeminal neuralgia, refractory or intolerant to medical treatment, are randomly assigned (after signing a consent form), to receive one of two percutaneous procedures. The patients are evaluated a week before and a week, a month, two months, three months and six months after the surgery.

The questionnaires (Short-Form of the McGill Pain Questionnaire - SF-MPQ, Douleur Neuropathique - DN4, Neuropathic Pain Symptom Inventory - NPSI, Brief Pain Inventory - BPI, Global Clinical Impression - GCI, Hospital Anxiety and Depression - HAD, Brief World Health Organization Quality of Life Questionnaire - WHOQOL-brief, Pain Catastrophizing Scale - PCS) and tests (Quantitative Sensory Testing - QST, olfactory threshold - OT - and discrimination - OD, taste threshold - TT, and salivatory quantification - SQ) are applied as follows:

* Pre-op evaluation: SF-MPQ, DN4, BPI, NPSI, HAD, WHOQOL-brief, PCS, QST, OT, OD, TT, SQ.
* First visit post-op: SF-MPQ, BPI, NPSI, GCI
* Second visit post-op: SF-MPQ, BPI, NPSI, GCI
* Third visit post-op: SF-MPQ, BPI, NPSI, GCI
* Fourth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, TT, SQ.
* Fifth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, OD, TT, SQ.

Patients with pain recurrence are excluded after the last visit attended. An exploratory analysis is made with 30 patients for a proper sample size calculation during the study.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Trigeminal Neuralgia
* Refractory/Intolerable medical treatment
* Pain restricted to second or third trigeminal division

Exclusion Criteria:

* Secondary Trigeminal Neuralgia
* Pain restricted to the first trigeminal division
* Refuse to participate
* Unable to comprehend the questionnaires
EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)

This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).

Intravitreal injection therapy (IVT) of anti-vascular endothelial growth factor (VEGF) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. The most common adverse effects of IVT occur due to the side effects of Povidone-Iodine 5% (PI; brand name: Betadine® 5%; Alcon, Fort Worth, TX), the antiseptic placed on the ocular surface prior to each injection. PI is nearly universally used to prevent ocular infection (endophthalmitis). PI leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT. Post-IVT pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. Therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
4. Currently receiving intravitreal steroid injections
5. Concurrent participation in another clinical trial
Atrial Pressure Electrophysiology Pilot Study

This study examined data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation-radiofrequency catheter ablation. A high flow catheter delivers a high volume of saline during the procedure. The low flow catheter delivers a low volume of saline during the procedure. The patient will be consented and randomized to one of the 2 groups using a computer generated randomization chart. Those that are put in the low flow catheter group will be considered the experimental group. All data will be collected before and after the procedure and each patient will act as their own control within each group.

Final report

Eligibility Criteria:
Inclusion Criteria:

* Drug resistant paroxysmal AF
* ≥ 18 years old

Exclusion Criteria:

* Left atrial thrombus on TEE
* Patients unable to provide informed consent
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.

Eligibility Criteria:
Inclusion Criteria:

* Primary bilateral knee osteoarthritis with refractory to conservative treatment
* Patients who accept participation in the research and the randomization

Exclusion Criteria:

* no history of malignancy
* less than 75 years old
* severe cardiac insufficiency and morbid obesity
Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery

Arterial and venous thromboembolism represents one of the most common preventable health problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis, the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly 4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.

Rivaroxaban is the first agent of a new class of drugs acting as direct factor Xa inhibitors with oral bioavailability. Highly selective inhibition of factor Xa by rivaroxaban is expected to inhibit the amplified burst of thrombin generation and may result in more effective inhibition of thrombus formation with a favorable safety profile. In Thailand rivaroxaban is indicated for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs including surgery for hip fractures. There are limited number of observational studies of rivaroxaban in thromboembolism after hip fracture surgery as the approved indication in most countries are for thromboprophylaxis in hip and knee arthroplasty. The broader indications and the high number of hip fracture surgeries in Thailand allow us to explore a pattern of safety profile particularly bleeding complications and risk factors in patients receiving rivaroxaban thromboprophylaxis after hip fracture surgery.

Eligibility Criteria:
Inclusion Criteria:

* At least 50 years old in men or post-menopause in women
* Patients, who are undergoing standard surgery for fracture of the upper third of the femur, including femoral head, neck, trochanteric and sub-trochanteric fracture and the surgery is planned within 7 days after admission
* Patients, who are eligible for thromboprophylaxis. Such patients will be enrolled only after physician's decision to prescribe rivaroxaban for thromboprophylaxis has been made. The decision is totally based on standard of medical practice.
* Patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.

Exclusion Criteria:

* Trauma affecting more than 1 organ system
* Pathological fracture secondary to malignant disease
* Clinically significant bleeding excluding drainage
* Documented congenital or acquired bleeding disorder
* Patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to FDA-approved product label
* Patient on oral anticoagulation therapy in the past 7 days
* Pregnancy or breastfeeding
* Patients who are simultaneously participating in a different study
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Medical history of chronic migraine for at least 6 months
* 15 or more headache days during a 4 week period

Exclusion Criteria:

* Previous use of any botulinum toxin of any serotype for any reason
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
* Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit
Glycine vs Placebo for the Schizophrenia Prodrome

Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Eligibility Criteria:
Inclusion Criteria:

* meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

* history of psychosis
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with diabetic macular edema
* History of vitrectomy
* Central retinal thickness ≥ 275 µm
* Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

* Known anticipated need for ocular surgery during the study period
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known allergy to the study medication
* Known steroid-responder
* Use of systemic steroids
* Female subjects that are pregnant, nursing or planning a pregnancy
The Clinical Research of Needle Electrodes Used in Bispectral Index to Monitor the Depth of Anesthesia

In this study, the EEG information of patients was collected by different BIS electrodes, in order to compare the quality of EEG signals obtained by subdermal needle electrodes and the original BIS sensors, and try to use primitive EEG signals to develop a new calculation of needle electrode to monitor the depth of anesthesia.

After the patient enters the room, non-invasive BP, HR, end-tidal CO2, SPO2 and other routine monitoring are performed, and the corresponding BIS electrodes are worn to the patient. The anesthesiologist decides whether to perform invasive hemodynamic monitoring, such as invasive arterial blood pressure monitoring, central venous pressure monitoring, etc., depending on the patient's condition and surgical requirements. The induction and maintenance of anesthesia is the routine scheme in the Second Affiliated Hospital of Zhejiang University , and the medication and dose are based on the judgment of the main anesthesiologist . After induction, endotracheal intubation was performed and mechanical ventilation was given. After anesthesia induction, install subcutaneous needle electrode to the patient. BIS values were collected using two BIS monitoring systems, one using the original BIS sensor and the other connected to the needle electrodes.During the operation, the anesthesiologist adjusted the depth of anesthesia according to the original BIS value, and propofol was used to improve the depth of sedation if the BIS value was greater than 60. In this study, surface acoustic wave electronic nose was used to monitor the exhaled propofol concentration of patients undergoing general anesthesia.The BIS value, hemodynamic information, exhaled propofol concentration and plasma propofol concentration were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASAⅠ\~Ⅲ
* Over 18 years old
* Patients undergoing General Anesthesia surgery requiring BIS Monitoring
* Obtained informed consent

Exclusion Criteria:

* Patients who have mental disorders and unable to answer
* Patients who have taken anti-epileptic drugs and psychotropic drugs for a long time
* Patients who are pregnant
* Patients who refuse to participate in this trial
* Patients considered by the investigator to be unsuitable for inclusion in the trial