cyrilzakka/clinical-trials huggingface dataset:
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

The evidence is insufficient to determine whether the types of dressings containing silver differ in time / proportion for complete wound healing and pain. We will analyze the cost-effectiveness of these dressings in outpatients, considering the service provided by the Brazilian National Public Health System.

Randomized, single-center, single-blinded, controlled clinical trial. Adult patients (age between 18 and 65 years), regardless of sex, with second degree burns treated in outpatient regimen will be randomized (1:1) into two groups: 1% silver sulfadiazine and nanocrystalline silver.

Primary outcome:

- Proportion of lesions completely epithelialized within 15 days.

Secondary outcomes:

* Time in days for complete epithelialization of the burned areas;
* Number of dressing changes;
* Level of pain associated with the application and removal of the dressings;
* Direct medical and non-medical costs;
* Need for surgery;
* Incidence of infection;
* Presence of local adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 65 years;
* Regardless of sex and ethnicity;
* Presenting second degree burns (partial thickness involving the epidermis and part of the dermis, with at least the preservation of some dermal appendages from of which the wound can eventually be epithelialized spontaneously) (ARTZ; MONCRIEF; PRITT, 1980) under an outpatient regimen, without the need for surgical debridement of devitalized tissue and skin grafts informed in the initial clinical diagnosis.

Exclusion Criteria:

* Patients with diabetes;
* Pregnant women;
* Patients with intellectual disabilities;
* Patients with burns to the face or on the palmar face of the hands or on the plantar face of the feet, as the need for specific treatment was felt to prevent functional sequelae;
* Patients who have already started treatment in other institutions;
* Those whose burns had happened 5 or more days before their entrance in the hospital;
* Those incapable of signing the informed consent form or who have declined to participate.
Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)

The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.

To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Be age 30 to 79
2. Give written informed consent for trial participation
3. Must have shoulder pain for a minimum of 6 months but less than 5 years
4. Must have a Pain Intensity Score of \> 5
5. Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
6. Must have a stable pain medication regime 1 month prior to treatment
7. Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose

Exclusion Criteria:

1. Any history of full thickness rotator cuff tear or joint effusion
2. A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
3. Has had more than 2 corticosteroid injections in the previous 3 months
4. Has an infection or an inflammatory condition of the trial shoulder
5. Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout
6. Has severe joint effusion of the trial shoulder
7. Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
8. Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
9. Has a hypersensitivity to HA products, eggs, birds or feathers
10. Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
11. Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease
12. Is actively involved in a litigation involving Workers' Compensation
13. Is a female that is pregnant, planning to become pregnant or is lactating
14. Has participated in a clinical trial within the past four weeks
Educational Intervention for Asthmatic and Allergic Patients

Despite its importance, there are few studies that implement the use of new technologies in the approach to patients with asthma and allergy. Therefore, the objective of this study is to evaluate the effectiveness of a telematic educational intervention in patients with allergies and / or asthma


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic and allergic patients

Exclusion Criteria:

* Cognitive impairment.
* Diagnose of autism spectrum disorder or severe intellectual disability
* Physical or functional impairment that limits the performance of evaluation
A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)

The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex between 18 and 65 years of age (both inclusive).
* Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.

Exclusion Criteria:

* Present infection (infection signs should not be evidenced).
* Other lesions which interfere with the body weight load.
* Open pseudoarthrosis (at the time of inclusion).
* Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
* Other conditions or circumstances that compromise the study participation according to medical criteria.
Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients

Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2 ≤ body mass index ≤ 30kg/m2).

50 participants per arm (acarbose \& lifestyle combination / vildagliptin \& lifestyle combination), using abdominal computed tomography scans and other methods to evaluate the effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity patients with newly diagnosed type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* All patients was diagnosed within the past 12 months with type 2 diabetes patients (WHO, 1999 criteria ).
* Not received oral anti-diabetic drugs or has been on short-term(1month) treatment that had been discontinued 3 months before enrollment.
* 30 ≤ Age ≤ 70 years old, male or female.
* HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).
* 24 ≤ BMI ≤ 30 kg/m2.
* Written Informed consent.

Exclusion Criteria:

* Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM.
* Those who can not tolerate AGI or who is suffering GI disease.
* Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia.
* Known or suspected allergy to trial product(s) or related products.
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
* Impaired liver function, defined as ALT≥2 or AST≥ 2 times upper referenced limit times upper normal limit.
* Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection.
* Endocrine diseases (hypo thyroidism, hyperthyroidism,Cushing's syndrome).
* Uncontrolled hypertension(SBP≥180mmHg and/or DBP≥100mmHg).
* Diabetic ketoacidosis; or hyperosmolar non-ketotic coma.
* Concomitant treatment which influences blood glucose and bodyweight.
* Impaired renal function(Cr≥ 1.5 mg/dl in male or Cr≥1.4 mg/dl in female).
* Mental disorders; drug or other substance misuse.
* Participation in any drug clinical trials during the past 3 months before enrolment.
Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control

Study is an observational study among hypertensive patients

Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.

Eligibility Criteria:
Patient inclusion criteria were as follows:

* aged between 38 and 74 years,
* hypertension diagnosis history of at least 6 months
* use of at least one antihypertensive medication.

Exclusion Criteria:

-not willing to join the clinical trial
Queen's University Investigation of Calcification in Chronic Kidney Disease

Kidney disease is a fundamental part of medicine because of its prominence in Western society. Common conditions such as diabetes, hypertension and kidney infections can all progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD 5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to effectively clear harmful toxins from the blood.

A common feature of ESRD is vascular calcification, a process where blood vessels (especially arteries) attract deposits of the mineral calcium. Over time, these deposits harden and thicken in the layers of blood vessels, which limit blood flow to body tissues and can produce significant disease including hypertension, heart disease and stroke. Although the process of vascular calcification is unknown, there is mounting evidence that it is mediated by cellular events that are similar to those seen in bone formation with in the body (osteogenesis). With this point in mind, it has been suggested that agents medicine employs to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.

This study will employ one group of drugs called bisphosphonates which have been used to limit bone formation. It will study their effect on vascular calcification in adult dialysis patients.

Presently, there exist few therapies aimed at retarding the progression of vascular calcification. One study showed that agents that limit the absorption of phosphate from food (phosphate binders) slow the progression of vascular calcification, and as a result, treatments emphasize phosphate control through diet and phosphate binders. Other studies have shown that the use of statins, to lower LDL cholesterol levels may reduce the progression of coronary calcification in non-ESRD patients, but data from ESRD are lacking. While these treatments have been helpful, the improvements in patients' outcomes have not been overwhelming positive.

This proposed study is not the first to study the use of bisphosphonates on vascular calcification. Repeated studies have shown impressive reduction in calcification rates in several animal models, which begs the question, how will bisphosphonates fare in human subjects? Preliminary research has begun, but clearly an expansive trial on humans is needed to explore the use of a promising therapy. Our study hopes to provide insight into this area of cardiovascular research.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* receiving maintenance renal replacement therapy for less than 12 months
* incident patients starting renal replacement therapy for the first time

Exclusion Criteria:

* active vasculitis
* severe hypocalcemia
* previous adverse side effect to bisphosphonate use
* current use of corticosteroids
* weight greater than 300 pounds
* pregnancy
* not expected to survive greater than one year
* expected to discontinue renal replacement therapy during the study period or recover renal function
* evidence of adynamic bone disease
* current bisphosphonate use
Dry Needling in Patients Who Had Experience Stroke

Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke


Eligibility Criteria:
Inclusion Criteria:

* First-ever unilateral stroke;
* hemiplegia resulting from stroke;
* unilateral equinovarus gait with independent walk;
* able to ambulate without supporting devices

Exclusion Criteria:

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
* not independent in the basic activities of daily living
* cognitive deficits;
* progressive or severe neurologic diseases;
* fear to needles;
* any contraindication for dry needling
Not Invasive Monitoring of Pleural Drainage

This study investigates if data about monitoring the drainage of pleural effusion can be collected by non invasive sensors (feasibility).

25 patients \> 18 years old with pleura effusion will be examined with regard to the feasibility of non invasive sensor measurements corresponding to the course of thorax impedance and respiration parameters during body fluids loss before and after pleural drainage. The measured data will be compared to standard routine reference measurements (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Also 25 healthy controls will undergo the same measurements to receive standard values.

Eligibility Criteria:
Inclusion Criteria:

* patients with pleural effusion undergoing pleural drainage
* male and female patients aged at least 18 years

Exclusion Criteria:

* pregnancy or breast feeding
* implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol".
* patients not being able to consent
Precision Analgesia for Cardiac Surgery

The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.

Cardiac surgery patients often experience significant acute postoperative pain, and untreated or undertreated pain has consequences. Each year, 900,000 painful cardiac surgeries occur in the US alone. Pain associated with cardiac surgery results from surgical incision, sternal retraction, internal mammary artery harvesting, saphenous vein removal, placement of mediastinal and chest drains, sternal wires, and release of pro-inflammatory mediators after tissue injury. One study reported that 49%, 62%, and 78% of patients reported severe pain at rest, movement, and coughing, respectively after coronary artery bypass surgery (CABG). Another study showed that 61.4% of patients undergoing cardiac surgery reported moderate to severe pain. Inadequate pain treatment is common in cardiac surgery due to health care providers' fears of causing cardiorespiratory compromise. Poor pain control can trigger sympathoadrenal responses leading to cardiac arrhythmias and myocardial ischemia, restrict mobility to cause venous thrombosis, impair clearance of secretions leading to pulmonary complications such as atelectasis and pneumonia, decrease patient satisfaction and predispose to the development of chronic, persistent surgical pain (CPSP).

Improving clinical practice by shifting paradigms: Our research is transformative and will evolve current reactive clinical practice towards proactive precision methods based on genetic risks for surgical pain and ORADE in elderly vulnerable population. This is the first effort to move in the direction of personalizing perioperative opioid use with precise dosing to improve safety and efficacy in cardiac surgery. Preoperative genotyping-based clinical decisions are expected to support clinical implementation in real-world settings. Importantly, investigators will be able to reach beyond the current best-in-class outcomes with precision multi-dose methadone analgesia based on proactive genetic risk identification to maximize safety and efficacy of opioids in all cardiac surgical patients and positively impact socio-economic outcomes in the future. By addressing these critical barriers, this research will help physicians identify patients at risk and improve the safety and efficacy of opioids and surgical pain management while preventing OD, misuse, overdose, and deaths.

Eligibility Criteria:
Inclusion Criteria:

* Elderly cardiac surgical patients over 60 years of age

Exclusion Criteria:

* Methadone allergy
* Morbid obesity (BMI \>40kg/cm2)
* Severe sleep apnea
* Severe pulmonary disease requiring oxygen therapy
* Preoperative mechanical circulatory support
* Emergency surgery
* Liver disease (liver enzymes more than two times normal)
* End-stage renal disease requiring dialysis
* Serum creatinine more than 2.0mg
Eat Well Live Well Nutrition Program

The purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and skills training through active learning exercises related to healthy eating. The program is delivered by peer educators in the community and addresses economic and cultural factors that are very important to program participants.


Eligibility Criteria:
Inclusion Criteria:

* African-American Women
* Aged 25-55 years
* No current diabetes, obese (20% over ideal body weight)
* In community neighborhoods
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is male or female between 18 and 75 years old, inclusive.
2. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization.
3. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour.
4. Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab
5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.

Exclusion Criteria:

1. Patient has taken more than 2 biologic agents.
2. Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study.
3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
4. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
5. Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.
Validation of an Instrument to Qualitatively and Quantitatively Profile Hospitalist Workflow

The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld computer's time-motion program can be used to record reliably what a hospital-based doctor does while working a shift in the hospital. In this study reliability will be measured by comparing the data collected by at least two different observers recording data from the same hospitalist during the same period of time.

We were unable to configure the software to get started on this study.

Eligibility Criteria:
Inclusion Criteria:

* Must be a practicing hospitalist, defined as a physician working exclusively in a hospital settings

Exclusion Criteria:

* None
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

* Female, Age between 18 to 45 years (inclusive).
* Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg.
* With a history of sexual activity
* Regular menstruation cycle (25 to 35 days, inclusive).
* Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
* Reached the standard within the time window after receiving the down-regulated drug.
* Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
* Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.

Exclusion Criteria:

* History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator.
* Unexplained reproductive tract bleeding.
* Thin-layer cytology examination deemed clinically significant by the investigator.
* Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with.
* Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination.
* Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs
* Consume strong coffee or tea daily
* Historic abuse of alcoholic beverages
* Smoke ≥5 cigarettes per day within 3 months prior to the study
* History of drug abuse
* Unsuitable for participation by the investigator.