cyrilzakka/clinical-trials huggingface dataset:
Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee

The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown that this improvement may be highly variable based on the time from treatment, especially in the first 12 weeks following treatment. The purpose of this study is to document the outcomes following a treatment protocol in which corticosteroid is used in addition to the initial Synvisc injection in the series of three injections.

Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated scoring systems. Following injection, patients will receive a diary to document any adverse events between the first and second injection. In one week, patients will return for a second visit to receive the second injection. Again they will be asked to maintain their diary of adverse events following the second injection. The patient will then receive the final injection at week 3 and will again complete a diary of events for one week. At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of injections, the patients will complete a form that will include the pain, stiffness, and physical function subscales of the WOMAC score and a 10 point patient satisfaction question.

At 6 months, the patients will receive by mail the same questionnaire packet they received at baseline, with the addition of patient satisfaction and subsequent injury/treatment questions.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 80 years
* with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.

Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.

Exclusion Criteria:

* Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
* Patients with a prior synovectomy on knee to be injected will be excluded.
* Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
* Patients who have undergone a prior synovectomy will not be included.
Peer Comparison-based Risk Communication

The study objective is to evaluate the feasibility of delivering a risk communication intervention, Peer comparison-based Risk Communication (PRICOM), in the primary care setting for adults with poor T2DM control. Findings from the study will inform further revisions to PRICOM and provide an estimated effect size to estimate the required sample size for a multi-site trial.

Background: Younger adults with Type 2 Diabetes Mellitus (T2DM) in Singapore tend to have poorer glycaemic control and medication adherence, factors correlating with high risk of diabetes complications. Late-stage diabetes and its complications are perceived to be slow-progressing and not immediately life-threatening. These reflect a concerning state of diabetes control and risk perception in Singapore. Using the Health Belief Model, a risk communication intervention, Peer comparison-based Risk Communication (PRICOM), was developed for physicians to counsel patients with T2DM supported by a digital tool. PRICOM aims to promote health actions by increasing their risk perceptions of diabetes complications.

Specific aims: The primary aim is to evaluate the feasibility of delivering PRICOM in the primary care setting for adults with poor T2DM control - in terms of recruitment, retention, PRICOM adherence, estimated effect size of score changes in risk perception, health actions and HbA1c change. Secondary aims are to assess validity of the risk perception scale, and to explore patients' perspectives of PRICOM.

Methodology: A multi-site randomised controlled trial will be conducted at a primary care clinic in 2 concurrent phases. In phase 1, content validation and test-retest reliability of a risk perception scale will be carried out. In phase 2, a two-arm randomised controlled trial will be conducted using mixed-methods to evaluate the feasibility of delivering PRICOM. A total 40 patient participants will be recruited by convenience sampling. Eligible patients must be age 40-79 years and have poor T2DM control with at least one HbA1c reading ≥ 8.0% within the last 6 months.

Relevance/significance of the study: Findings from the study will inform further revisions to PRICOM and provide an estimated effect size to estimate the required sample size for a multi-site trial.

Eligibility Criteria:
Eligibility criteria for patient participation:

* T2DM on follow-up at the respective study site for at least 12 months
* Age 40 to 79 years
* At least one HbA1c reading ≥ 8.0% within the last 6 months
* Able to read and speak English

Exclusion criteria for patient participation:

* Not a Singapore citizen or permanent resident
* Pregnant
* End-stage kidney disease or on renal replacement therapy
* Known terminal illness
* Visual and/or hearing impairment
* Cognitive impairment or mental illness
* Unable to provide informed consent
Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP circadian rhythm is altered and varied widely between patients. To date, the only way to evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour hospitalization. This method is expensive and does not reflect physiological conditions because it requires IOP measurements during sleeping periods that may potentially produce artifacts.

Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. Then we will also analyze the influence of corneal parameters on continuous IOP fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.


Eligibility Criteria:
Inclusion Criteria:

* At least 40 year-old
* Signed informed consent
* Visual field defect : at least 2 visual field already done, only the second one is considered for the visual field defect diagnosis, using theses criterion:

  * 3 adjacent points with at least 5db loss
  * Or 1 point with at least 10 db loss
  * Or a 10db difference between two adjacent points on either sides of the nasal horizontal meridian
* Open angle glaucoma patients with a progressive visual field
* For women of childbearing potential, adequate contraception

Exclusion Criteria:

* Corneal dystrophy, scars or corneal surgery
* Iridocorneal angle opening less than 3 using Shaeffer classification
* History of glaucoma surgery
* Any contraindications with the SENSIMED Triggerfish® device, as written in the user manual (active eye disease, severe dry eye, contraindications for silicone contact lens wear...)
* Diabetes
* Sleep Apnea Syndromes
* Cataract surgery
* High myopia
* Pregnancy and lactation
* Patients not able to understand the character and individual consequences of the investigation
The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV

To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.

At present, as the mainstream antiemetics of CINV, oral administration is the most commonly used method of drug therapy. Clinical studies showed that there was no difference in the efficacy of 5-HT3 receptor antagonist between different administration routes (oral and intravenous). At the same time, because the oral route is the most convenient, oral preparations provide more and more convenient choices for clinicians and patients. To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* For patients with malignant tumors who can accept chemotherapy, the disease type is not limited. The specific chemotherapy scheme is the chemotherapy scheme with moderate risk of vomiting (for the risk level of vomiting, refer to the 2019 CSCO anti-tumor treatment related nausea and vomiting prevention and treatment guidelines);
* 18-75 years old, KPS score ≥ 70, and the expected survival time is more than 3 months;
* Before treatment, ECG, blood routine test, liver and kidney functions and electrolytes were basically normal;
* All patients signed the informed consent form

Exclusion Criteria:

* Patients with chemotherapy contraindications, patients allergic to 5-HT3RA, pregnant women and lactating women;
* People with digestive tract obstruction; Patients with serious heart disease, liver and kidney disease and metabolic disorder; Patients suffering from epilepsy or using psychotropic and sedative drugs;
* Used antiemetic drugs or chemicals within 24 hours.Those who have vomited before treatment may have brain metastasis, intracranial hypertension, gastrointestinal obstruction, psychological abnormalities, etc.Patients with factors causing nausea and vomiting.
Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

This study is being conducted in patients with a major heart attack caused by a blocked artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. At present the best way to manage these additional blockages is not known. Many cardiologist recommend opening these blockages at at a later time after the heart attack. The present study is examining if PCI of all blockages at the same time as the PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI). Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.


Eligibility Criteria:
Inclusion Criteria:

* ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads.
* MVD as evidenced by \> one significant (\>70% by visual assessment or FFR \< 0.80 for 50-70% stenosis) stenosis in the non-IRA \>2mm in diameter.
* Successful IRA-PCI with \<30% residual angiographic stenosis and TIMI III flow
* Written informed consent

Exclusion Criteria:

* Age ≤ 18 years
* Prior coronary artery bypass graft (CABG) surgery
* Administration of thrombolytic therapy.
* Hemodynamic instability as evidenced by SBP\<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors.
* Known renal insufficiency (estimated GFR \< 30 ml/min/1.73m2)
* Non-IRA stenosis is a chronic total occlusion (CTO)
* Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery
IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age

Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension

Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.

Diabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.

Eligibility Criteria:
Inclusion Criteria:

All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

Exclusion Criteria:

* 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors

This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.

PRIMARY OBJECTIVE:

I. To record electrocorticogram (ECoG) data intraoperatively with surface electrode grids during various motor, sensory (tactile) and speech tasks, and identify functional brain areas through the spectral analysis, and compare the preliminary data with our current pre-surgical mapping methods: functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS), and the gold standard, intraoperative direct electrical stimulation (DES).

SECONDARY OBJECTIVE:

I. To perform a preliminary assessment of the utility of using ECoG data in these patients to quantify new neurological and language/speech deficits in the short term (24 hours) and long-term (1, 3, and 6 months), and achieve a safe maximal tumor resection.

OUTLINE:

Patients undergo tumor resection. During surgery, patients also undergo electrocorticography with either the CorTec high resolution hybrid grid, the PMT high-resolution grid, or the Ad-Tech grid followed by direct electrocortical stimulation.

Following completion of study, patients are followed up within 24 hours from surgery and at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and/or speech brain areas
* Patients \>= 18 years of age
* Signed informed consent

Exclusion Criteria:

* Patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)
* Patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the PI
Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Tumor diameter \< 5 cm
* Low grade ductal carcinoma in situ
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 5 cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth

The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.

Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. One sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. Additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. Also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.

Eligibility Criteria:
Inclusion Criteria:

* women at the day 42th of post-partum fully breastfeeding-

Exclusion Criteria:

* baby premature
* diabetes
* blood hypertension
* not breastfeeding or partial breastfeeding
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

This study compared exposure to one of two web-based treatments in self-reported improvement of posttraumatic stress disorder (PTSD) symptoms in adults with at least one lifetime traumatic event and elevated posttraumatic stress symptoms.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking individuals
* Experience of at least one lifetime traumatic event, as measured by the Life Events Checklist
* Score of 25 or higher on the PTSD Checklist for DSM-5

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Prisoners
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome

The purpose of this clinical trial is to evaluate the safety and effectiveness on the clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin and/or probiotics administration.

Probiotics are live bacteria that offer a health benefit to the host when administered in adequate amounts. Probiotic supplementation is safe for use and has demonstrated beneficial effects for metabolic diseases such as obesity and diabetes. In this study, about 90 reproductive-aged women with PCOS will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin tablets (0.5g tid po), ProMetS probiotics powder (4g qN po), Metformin tablets (0.5g tid po) and ProMetS probiotics powder (4g qN po), for 12 weeks. Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, sex hormone levels, serum lipid profiles, inflammation markers, other metabolic related parameters and change of gut microbiota and immune cells will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal between 18-40 years of age.
2. Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.

Exclusion Criteria:

1. During the pregnancy and lactation period.
2. Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
3. Use of antibiotics within 3 months.
4. Symptoms of any infection at screening.
5. Immunodeficient or use of immunosuppressive drugs.
6. Use of products containing prebiotics or probiotics within the last 3 months.
7. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
8. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator