cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

PRIMARY OBJECTIVES:

I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine change in lesion size in these patients after treatment with this drug.

II. Compare histologic response before and after treatment with this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.

Arm II: Patients receive standard care.

At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed grade III cervical intraepithelial neoplasia

  * Confirmed by biopsy or colposcopy
* Positive for human papilloma virus 16
* No endocervical glandular dysplasia
* No adenocarcinoma in situ
* Performance status - GOG 0-2
* No life-threatening or serious hematological disorder
* No life-threatening or serious hepatic disorder
* No life-threatening or serious renal disorder
* No life-threatening or serious cardiac disorder
* No life-threatening or serious respiratory disorder
* HIV negative
* Must be immunocompetent
* No history of autoimmune disease
* No life-threatening or serious immunological disorder
* No prior or concurrent severe allergic disease
* No concurrent human papilloma viral infection other than type 16
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No life-threatening or serious gastrointestinal disorder
* No life-threatening or serious endocrine disorder
* No invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No concurrent chronic or systemic steroids
* No prior organ transplantation
* No prior cancer therapy that would preclude study therapy
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.

The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. In the absence of large randomized controlled trials, we will conduct a large collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients undergoing primary transfemoral TAVI with either MCV or ES valve.

The main aim of this patient-pooled analyses is to compare stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. However, this collaboration may also be used to compare various outcomes.

Studies were included if they complied with the following requirements: original prospective studies, including patients with aortic valve stenosis treated with transfemoral TAVI of native valves and reporting of 30 day stroke outcomes according to VARC criteria or other specified corresponding criteria . Moreover, to be included studies had to report both the use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50 patients in each arm to ensure experience in use of the valves. Studies were excluded if they only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or included the same study population. Principal Investigators of these studies were approached for collaboration.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion Criteria:

* valve-in-valve procedures, other acces routes than transfemoral
Pain Management In Knee Osteoarthritis

In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain.

Knee osteoarthritis (OA), also known as degenerative joint disease of the knee, is typically the result of wear and tear and progressive loss of joint cartilage. Knee osteoarthritis can be divided into two types, primary and secondary. It is most common in the elderly. The intensity of clinical symptoms can vary from person to person. However, they typically become more severe, more frequent, and more debilitating over time. The rate of progression also varies with each individual. People suffering from knee osteoarthritis complain of limited range of motion and pain when they move their knee or start walking. In advanced disease, they may complain of nocturnal or persistent knee pain and the functionality of the joint is severely impaired. Knee osteoarthritis treatment begins with non-surgical (conservative) treatment methods. Non-surgical treatment includes patient education, lifestyle modification, and the use of orthotic devices. It has been shown that untreated pain in the elderly can have a general impact on their quality of life and lead to depression, anxiety, social isolation, cognitive impairment, inactivity, and sleep disorders. The aim of our project is to provide training for patients diagnosed with knee osteoarthritis with chronic pain to be able to control their pain with self-management and to perform activities of daily living more easily. Appropriate knowledge and awareness can improve their quality of life. Performing safe and accurate pain management practices in the elderly can improve their performance, quality of life, increase their comfort and reduce their care costs. In this study, it was aimed to investigate the effect of pain management education in individuals with knee osteoarthritis with chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR)
* Be between 45 and 75 years old
* Stage 2-3 according to Kellgren Lawrence (K-L) in the radiological examination

Exclusion Criteria:

* Having active synovitis
* Receiving physical therapy in the last 6 months
* People with neurological problems that affect walking
* Those with arthritis in the ankle and hip joint
* Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise.
* Have had surgery on the lower extremity in the past
* Intra-articular steroid injections in the last 6 months
* Use of psychoactive drugs
Vitamin C in Atrial Fibrillation Ablation

Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV infusion time per dose, compared to matched placebo infusion


Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 21 years
2. Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure
3. Ability to provide informed consent and willingness to be included in the study

Exclusion Criteria:

1. Known allergy to Vitamin C
2. Inability to obtain informed consent
3. Diabetes mellitus either requiring the use of insulin therapy or not requiring the use of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of greater than or equal to 8%
4. Prior catheter-based ablation for atrial fibrillation
5. Pregnancy or breast feeding
6. Active renal calculus
7. Active acute or chronic infection (including HIV or hepatitis C)
8. Active or recent (within 5 years) malignancy
9. Autoimmune or autoinflammatory disease
10. Recent or active use of immunosuppressive medications
11. Non-English speaking
12. Ward of the state (inmate, other)
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome

This study will be conducted toinvestigate the effect of Global Postural Re-education on low back pain patients with Lower cross syndrome

Lower cross syndrome is common, with up to 85% of low back pain cases due to long-term postural faults (Lower crossed syndrome) and it has a negative result on our society. Global Postural Re-education (GPR) is an intervention that is used frequently for chronic low pain to improve pain and function. 50 low back pain patients with lower cross syndrome will be assigned randomly into 2 groups, Group A will receive a Global Postural Re-education approach and consists of 15 treatment sessions of Global Postural Re-education approach, performed 2times/week for 1 hour including patient education. Each treatment is individualized for every patient and for his/her pain-related limitation. Each session includes only 2-3 postures to increase the standardization of treatment. Group B will receive the conventional treatment in form of exercise program of (abdominal and pelvic floor strengthening) and (stretching exercise of back and hip flexor muscles) to improve pain and function in chronic low back pain patients

Eligibility Criteria:
Inclusion Criteria:

* 50 patients.
* Both sexes will be included.
* Patients' age range will be 25 to 40 years old (Esakowitz., 2014).
* Participants will have to meet the criteria for lower crossed syndrome indicating tight hip flexors and erector spinae together with weak glutei and abdominals with low back pain will be presented three months or longer and level of pain intensity more than 3 on VAS.

Exclusion Criteria:

* On other forms of treatment that may interfere with the study including other physical therapy or medication specific to back pain.
* Enrolled in another interventional clinical research trial
* Pregnancy
* Nerve entrapment, bowel or bladder dysfunction and kidney disease.
* Surgery on the back, pelvis or sacrum is indicated or has previously occurred.
Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis

The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.

Over the past few years, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.

Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.

This prospective clinical study is going to assess the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.

Eligibility Criteria:
Inclusion Criteria:

* minimum age of 18 years(range from 18 year to 25 years)
* corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm
* preoperative spherical equivalent refraction between- 2.00 diopter (D) and -6.50 D.preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D.
* preoperative corneal curvature from 41.0 D to 46.0 D with a regular topographic pattern monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery。

Exclusion Criteria:

* systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease)
* corneal abnormality or disease.
* a history of tear supplement usage or contact lens wear during the past year.
Effect of Intensive Language Therapy in Subacute Stroke Patients

Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of language rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive language rehabilitation during subacute phase to improve language function in patients with first-ever strokes.

Intensive language rehabilitation group - language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks

Conventional language rehabilitation group

- language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* Acute first-ever stroke
* Left hemispheric stroke
* Korean version of Frenchay Aphasia Screening Test(K-FAST) \< 25 (less than 65 years old), K-FAST \<20 (65 years old and more than 65 years old) at 7 days after stroke onset
* Right handedness

Exclusion Criteria:

* Transient ischemic stroke
Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty

The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.

Patients scheduled to have total knee arthroplasty will typically receive a single shot adductor canal block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The use of adductor canal block is still limited to where trained anesthesiologists in regional anesthesia are available. There are other nonopioid analgesic adjuncts, such as Lidocaine, which is is widely available and is a very commonly used local anesthetic. A major advantage of lidocaine is that it is not associated with a significant side effect profile. Intravenous lidocaine which can be administered during surgery and/or after surgery has demonstrated anti-inflammatory effects and can significantly decrease the reliance on opioid use for adequate pain management in abdominal and spine surgeries. The addition of systemic lidocaine infusion as part of a multimodal analgesia strategy to minimize opioid related side effects might prove to be a useful combination for clinicians where adductor canal blocks are not a viable option. However, the level of evidence comparing the efficacy of intravenous lidocaine versus adductor canal block to reduce postoperative opioid consumption in patients undergoing TKA is limited. We hypothesized that there will be no meaningful clinical difference between systemic lidocaine and ultrasound-guided adductor canal block in the 24-hour postoperative analgesia period.

Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

Exclusion Criteria:

* ASA PS classification of 4 or greater
* Pre-existing neuropathy
* Coagulopathy
* Chronic opioid consumption (\>3 months)
* Infection at the site
* Known allergy to study medications (lidocaine)
* High grade atrioventricular block (cardiac conduction system impairment)
* A history of CVA/TIA
* Currently using lidocaine patches
* Known liver disease
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye

This study aimed to evaluate the efficacy and safety of 0.28% preservative-free SH and 0.18% SH eye drops in patients with dry eye disease. Subjects diagnosed with dry eye disease and meeting the inclusion criteria (Ocular Surface Disease Index (OSDI) score ≥ 23, Fluorescein Tear Breakup Time (TBUT) \< 7 seconds were randomized into two groups. Group 1 (42 eyes) received 0.28% SH, and Group 2 (42 eyes) received 0.18% SH, both administered by a nurse. Measurements included tear osmolarity (TearLAB) before instillation and at 0,30 and 60 minutes post-instillation, recorded by a TearLAB specialist. Ophthalmologists assessed TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation and evaluated adverse reactions up to 60 minutes post-instillation. Subjects continued treatment for 30 days and were reevaluated during a second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events. Quality of life score were assessed at before and after treatment for 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal 18 year-old
* Ocular Surface Disease Index (OSDI) more than or equal 23
* Oxford grading scale more than or equal 2 (both eye)
* Fluorescein tear break-up time less than 7 seconds (both eyes)
* Willing to being a subject in research.

Exclusion Criteria:

* Diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as Glaucoma
* History of Ocular surgery in previous 3 months or Refractive surgery in previous 6 months
* History of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months
* Wear contact lenses
* Allergic to Sodium hyaluronate
* Pregnant or lactation period
* Diagnosed with physical diseases that affect the eyes and cannot yet be controlled, such as uncontrolled DM (Diabetes Mellitus), active autoimmune disease, and systemic neuropathy induced neurotrophic keratopathy. - Continuous use of medications for diseases such as Retinoic acid derivatives, Antihistamines, Cholinergic agents, and Antipsychotic agents which can lead to chronic dry eye
* Incompleted data.
Approaches to Reduce Clinical Inertia in Hypertension in the Dominican Republic

The purpose of this cluster randomized control trial is to test whether a multimodality strategy that includes an educational on-line course and performance feedback reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.

Proper control of elevated blood pressure (BP) is complex due to the large number of factors associated with therapy such as patient lifestyle, therapeutic adherence and access to health care, especially in low and middle income countries. More recently another obstacle has been described; clinical inertia, defined as the failure of clinicians to initiate or intensify antihypertensive therapy despite elevated BP levels not at goal. Suboptimal therapy is the most clinically important modifiable factor known to be associated with poor BP control. Reducing clinical inertia is of significant relevance, since a proper control of hypertension can reduce mortality from coronary heart disease and mortality from cerebrovascular disease.

Our hypothesis is that a multimodality strategy that includes an on-line course on updated guidelines on hypertension management and feedback performance reports is effective to reduce clinical inertia in the management of hypertension in rural primary care clinics in the Dominican Republic.

To test this hypothesis, this study will enroll eight clinics in rural neighborhoods of the Peravia province. These are government-funded small clinics that provide primary care and preventive services and are staffed with 2-3 primary care physicians. Eight clinics will be randomized at a 1:1 ratio into a control group and and intervention group. We anticipate over 500 patients from these clinics will be included.

The primary care physicians in the intervention group will be provided with an on-line course and weekly performance feedback reports, based on the new American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology/European Society of Hypertension (ESC/ESH) hypertension guidelines. The performance feedback reports will include percent of patients with uncontrolled hypertension and among this group percent of visits where intensification in anti-hypertensive therapy was made. It will also include a comparative assessment of the performance of the physicians compared to their colleagues. The control group will continue to follow the current usual care without intervention. The total intervention and follow-up time will be 16 weeks.

Eligibility Criteria:
Inclusion Criteria for Clinics:

* Primary care clinics in rural areas of the Peravia province with primary care physicians (general practitioners, family medicine, internists).

Inclusion Criteria for Patients:

* Adult patients over age 18 who receive primary care at the participating clinics with history of hypertension or with blood pressure \>130/80 mmHg during the visit

Exclusion Criteria for patients:

* Pregnant patients
* Patients under age 18
Change in Patient Reported Outcomes and Wish for Joint Surgery

Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education.

Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee or hip osteoarthritis
* Date of enrolment between June 1st 2018 and September 30th 2021 (study period)
* Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)

Exclusion Criteria:

* No follow-up data
* No change in wish for surgery (participants remained either wishing or not wishing to undergo surgery for the whole treatment period). This exclusion was due to the focus of the present study on within-person relationships between PROMs and wish for surgery. In this scenario, those with no change in their wish for surgery do not provide any information to the analysis.