cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.

Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.

Participation in the study can be up to 4½ months.


Eligibility Criteria:
Inclusion Criteria:

Participants included in the study must:

* Have type 1 or type 2 diabetes mellitus.
* Have problems with the nerves in their feet.
* Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
* Be able to apply study drug to their ulcer, or have a caregiver do it.
* Be able to visit the doctor regularly during the 4½ month study.

Exclusion Criteria:

Participants may not participate in the study if:

* Their ulcer is caused by bad blood flow to their foot.
* Their ulcer is infected.
* They cannot wear a special boot during the study to take pressure off the ulcer.
* They have certain other diseases, or are using certain types of drugs.
Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery

This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.


Eligibility Criteria:
Inclusion Criteria:

* cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision

Exclusion Criteria:

* previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery
XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted, usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a sharp trocar is then inserted to hold the operating telescope.

The XCEL bladeless trocar is another method of inserting the operating telescope whereby you don't need to first introduce gas before the trocar. This trocar is widely used in laparoscopic surgery but it is uncommon to the field of gynecology.

This study will compare the two methods with regard to:

1. Time taken to enter the abdomen
2. The number of attempts taken to enter the abdomen
3. The impact of the time taken to enter compared to the whole operating time
4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of 1 to 5.

Patients will be recruited into the trial through the Monash Medical Centre Gynecology department and the Mercy Hospital for Women Gynecology department. Patients that are having laparoscopic surgery and would usually have a Veress Needle entry are suitable for this trial. A patient information sheet will be provided and written consent will then be obtained. Patients who give written consent will be randomised into one of two arms of the trial, either the control (Veress Needle) or the XCEL bladeless trocar arm.

Information will be entered on a proforma by a researcher for each patient during their operation. All patient information will be strictly confidential and only be available to researchers directly involved in the study.

Surgeons operating as part of the project are the consultants and fellow of the gynecology department of Monash Medical Centre and Mercy Hospital for Women and are competent in both techniques.

200 women will be recruited over a one year period and the data will then be analysed with the help of a statistician.


Eligibility Criteria:
Inclusion Criteria:

* Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments

Exclusion Criteria:

* Any women considered not eligible for a Veress Needle laparoscopy
Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia

Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and providing beneficial effects in bone metabolism. Stress induced by more vigorous activities such as weight lifting, increases the risk of injury, particularly in the elderly. Therefore, alternative strategies with lower risk of injury are indicated such as whole body vibration and walk.

Objective: Compare the effect whole body vibration and walking on muscular strength, balance and functional performance in the elderly with Osteoporosis and Osteopenia

Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will follow the guidelines established in the Consolidated Standards of Reporting Trials (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session. All participants will be subjected to the initial and final assessment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
* Patients without severe neurological disease, vascular disorders, labyrinthitis and blindness;
* No use of gait auxiliaries;
* No history of fractures of the lower limbs in the last year;
* Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points) accordance with the usual physical activity questionnaire (QAFH).

Exclusion Criteria:

-Patients who submit to hypertensive peak, nausea and dizziness during the training program.
Unlock the Secrets of Ageing Brains Through P300 Brain-computer Interface Games

The study will investigate the use of Electroencephalography (EEG) in understanding mild cognitive impairment (MCI). EEG is commonly used in everyday clinical practice for the assessment of a wide range of neurological disorders. It records the brains spontaneous electrical signals and offers a non-invasive means of visually evaluating brain signals. By analysing these signals, we aim to uncover invaluable insights into cognitive impairments and the ageing brains cognitive processes.

The Electroencephalogram (EEG) is widely used in clinical practice to assess various neurological disorders. It records the brains spontaneous electrical activity, providing a non-invasive way to visually examine brain signals. By analysing these signals, we aim to gain valuable insights into cognitive impairments and the cognitive processes of the ageing brain. The P300 is an event-related potential (ERP) that serves as a crucial EEG-based biomarker, whose amplitude and latency are key points of research in cognitive impairments. Typically elicited by a visual speller, the P300 could be used for the communication through brain-computer interface (BCI). A P300-based BCI enables communication by detecting the P300 response to specific target letters, allowing users to select letters they wish to spell through interactive interface. In this study, we will recruit 15 elderly participants with mild cognitive impairment (MCI) symptoms and 15 controls without MCI. We will customise the P300-BCI by adjusting the inter-stimulus interval (ISI) and the matrix size which is the probability of the target presenting. This will help us investigate how these parameter settings influence the P300 components and the accuracy of the P300-BCI in both groups. Additionally, this study could help explore the potential of the P300-BCI to mitigate MCI symptoms and provide evidence for its further development.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with mild cognitive impairments (MCI) or mild dementia
2. Normal or corrected-to-normal vision
3. Can maintain sitting with or without support for around 60 minutes continuously
4. Cognitive and language abilities to understand and participate in the study protocol and able to give consent and understand instructions

Exclusion Criteria:

1. Severe cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent
2. Pre-existing severe systemic disorders like active cancer, end-stage pulmonary or cardiovascular disease, psychiatric illness including severe alcohol or drug abuse
3. Past history of epilepsy- with seizures in last 12 months
4. History of photosensitive epilepsy.
5. Allergy to latex
Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a burden to health care and economic systems globally, to manage this preventable and treatable disease, different pharmacological and non-pharmacological interventions were shown to be effective.

Chronic and progressive dyspnea, cough and sputum production are the characteristic symptoms of COPD. The most commonly encountered symptom in patients with COPD is dyspnea, it is a subjective experience of breathing discomfort . It causes impact on patient's health status, sleep quality, anxiety and depression level. Therefore, skills transfer in self-managing major symptoms are crucial to prevent negative consequences, and as suggested by Global Initiative for Chronic Obstructive Lung Disease (GOLD), managing symptoms and to prevent future risk of exacerbations is important for stable COPD cases.

Basic Body Awareness Therapy (BBAT) is a physio-therapeutic intervention directed toward patients' functional movement quality. The development of BBAT was based on the hypothesis of persons' lacking contact with and lacking awareness on their own body, with their inner life, external environment and in the relation to other persons. Thus, it leads to dysfunctional movement, pain and other body functions. BBAT focus on multi-perspective within a person including physical, physiological, psycho-social-cultural and existential perspectives. It directs patients to be "aware", guides patients to have mental contact with their body, monitors internal sensations and external environment, and thus, to enhance the self-regulated behavior and positive emotional state.

There are three key components in practicing BBAT, namely balance, free breathing and mental awareness. Evidence shown that the effect of BBAT is significant in improving physical and psycho-social well-being in patients with different physical and mental disorders. Now, there is absence of evidence in applying BBAT in managing cases with respiratory diseases, especially for those with prominent symptoms of dyspnea (for example COPD cases).

The objectives of this study are (1) to evaluate individual BBAT as an add-on treatment in patients with COPD, (2) to understand COPD patients' experience through participating in individual Basic Body Awareness Therapy (BBAT).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD (ICD-9-CM 496.X) AND
* Ability to stand independently without aids, AND
* Subjectively experienced dyspnea, AND
* Ability to listen, speak, read and understand Chinese.

Exclusion Criteria:

* Patients with acute exacerbation of COPD within one-month, OR
* Patients with medical disorders possibly causing dyspnea (for example asthma, heart failure, etc.), OR
* Patients with major psychiatric or cognitive disorders, OR
* Patients refusal
Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm

Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable healthy patients (category: American society of anesthesiologists class I).
* The patient ranges in age from 20 to 40.
* No sexual orientation
* Necrotic pulp evaluated by thermal or electrical pulp testing.
* Enough crown structure to provide adequate isolation.
* One root and one canal.
* Patients' desire to engage in this research.
* Patients' comprehension of the visual analogue scale (VAS).
* Patients' ability to sign informed consent.

Exclusion Criteria:

* Endodontic treatment for the tooth previously.
* Teeth with poor conditions for using rubber dams.
* Vital pulp tissue was observed throughout the treatment.
* Patients who have a medical condition.
* Teeth with open apices that are immature
* Women who are pregnant or breastfeeding.
* Psychologically disturbed patients.
* Patients having a history of allergy to any of the research drugs were barred from participation.
* A periodontally affected tooth with grade 2 or 3 mobility.
Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors

RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the well-being and quality of life of cervical cancer survivors.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.

OBJECTIVES: I. To evaluate the utility of the 6 telephone sessions (low intensity: LiTx) and 8 telephone sessions (high intensity: HiTx) plus Survivorship Booklet designed to educate and improve awareness of the physical and psychological impact of cancer and increase knowledge of appropriate medical and psychosocial resources for women with cervical cancer. II. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve psychological functioning (decrease depression and anxiety) of women with cervical cancer. III. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve social functioning (family support and communication).

OUTLINE: Patients are clinically assigned to 1 of 2 groups. GROUP I: Patients receive a survivorship booklet in the mail that contains information about cervical cancer. Patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet. GROUP II: Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.

Eligibility Criteria:
Inclusion Criteria: Within 6 months to 3 years of a cervical cancer diagnosis Diagnosed with stages 1-3 invasive cervical cancer Not diagnosed with another type of cancer No other major disabling medical or psychiatric condition Survivors within 6 months to 3 years post diagnosis are included Participants must be able to read and/or speak either English or Spanish Women will not be excluded based on the type of treatment received for their cervical cancer or a history of diagnosis of mild depression or anxiety Exclusion Criteria: Women with metastatic disease Women with major medical conditions (e.g., stroke and degenerative illness) Survivors with moderate to severe depression or anxiety Asian participants Stage 0 disease
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease

The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.

It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.

Eligibility Criteria:
Inclusion Criteria:

* Doctor diagnosed cystic fibrosis, asthma
* Lung transplant recipient

Exclusion Criteria:

* Smoke history of less than 10 pack years
Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.

Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

Eligibility Criteria:
Inclusion Criteria:

Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes

Exclusion Criteria:

American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.