cyrilzakka/clinical-trials huggingface dataset:
Body Awareness and Functionality in Lymphedema

To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.


Eligibility Criteria:
Inclusion Criteria:

first group:

* being female,
* being aged 18-65 years,
* having undergone unilateral breast cancer surgery,
* being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
* not having any orthopedic disease that would prevent walking, and volunteering to participate in the study.

second group:The inclusion criteria for the breast cancer surgery group

* without lymphedema were being female,
* being aged 18-65 years,
* having undergone unilateral breast cancer surgery, and volunteering to participate in the study.

Lastly, the inclusion criteria for the control group were:

* being female,
* being aged 18-65 years,
* having no history of cancer surgery, and volunteering to participate in the study.

Exclusion Criteria: for all groups

* not being willing to participate in the study;
* the presence of metastases, neurological, or orthopedic disorders;
* postural deformities, such as scoliosis and kyphosis;
* mental and cognitive disorders; or communication/cooperation problems
Epidural PCA Related Adverse Effects in Young and Elderly

In this retrospective study, postoperative pain score, epidural patient controlled analgesia (Epi-PCA) related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl and ropivacaine-based Epi-PCA during postoperative 48 hours after various surgeries.

Since 2010, A PCA service team in the investigators' hospital have collected multidisciplinary clinical data from all the patients who used epidural-patient controlled analgesia (Epi-PCA) postoperatively in aim of the assessment of clinical outcome. The investigators reviewed the collected data from the patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015. The need for informed consent was waived for this study. For the Epi-PCA, fentanyl and ropivacaine was diluted and administered to the patients according to the clinician's determination.

The data of the PCA regimen which has been decided were recorded and analyzed. Demographic variables including age, sex, body mass index, American Society of Anesthesiologists (ASA) physical status and history of smoking, motion sickness, postoperative nausea/vomiting, hypertension and diabetes mellitus will be analyzed. Anesthesia and surgery-related variables including the duration of anesthesia, the type of anesthesia (general or spinal), laparoscopy and the operation site (categorized in abdominal, thoracic, upper \& lower extremities, head \& neck, spine and others) will be also analyzed. PCA-related variables including total dose of fentanyl for two days (µg/kg), use of mixed additional analgesics and antiemetics in PCA and discontinuation of PCA will be analyzed. Postoperative variables including the numeric rating scale (NRS, 0-10, 0 = no symptom; 10= unthinkable worst pain) for pain, requirements of rescue analgesics and antiemetics will be analyzed. In addition, the postoperative complications including nausea, vomiting, headache, dizziness, and sedation will be analyzed. All the recorded postoperative variables at post-anesthesia care unit, 6-12, 12-18, 18-24 and 24-48 hrs after anesthesia will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015.

Exclusion Criteria:

* Age \< 20 years old,
* Age 40 to 69,
* Routine use of analgesics/antiemetics
* Imperfect data
Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients

Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.

The present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients

Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis

Obtaining consent from patients participating in the study

Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.

Eligibility Criteria:
Inclusion Criteria:

* All the subjects should be within the age group of 18 to 55 years
* subject should have atleast 18 natural teeth excluding third molars.

Exclusion Criteria:

* History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.
* corticosteroids, in previous three months
* systemically compromised individuals
* smokers
* pregnant and lactating women
* Medical history for absence of systemic disorders such as diabetes mellitus
* cardiovascular diseases
* pneumonia
* tuberculosis
* rheumatoid arthritis
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, \>=18 years of age;
* chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
* no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

* blood transfusion within the previous 4 weeks;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).
Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question

Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL).

This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures.

Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy.

In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure.

The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.

Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.

Primary aim of the Hamlet trial is to demonstrate that mucopexy without DGHAL for grade III haemorrhoids have equivalent recurrence rate at 1 year follow up of DGHAL with mucopexy procedure

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic grade III hemorrhoids according to Goligher
* No other source of anal bleeding than hemorrhoids
* Written informed consent

Exclusion Criteria:

* Any previous hemorrhoid surgery
* Participants expressing clear preference for one of the interventions
* Pregnancy
* Inability to understand the informed consent
* Oral anticoagulants of congenital defects of the coagulation
* Patients with immunodepression (i.e. HIV)
* Other proctological diseases (fissures, fistulas, condyloma, etc)
* IBD involving the anus ore the rectum
Outcomes of Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequelea in Children With Spina Bifida

The aim of this study was to evaluate the safety and efficacy of autologous bone marrow mononuclear cell infusion in the management of neurological sequelae in children with spina bifida

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear cells in 11 patients with spina bifida at Vinmec Research Institute of Stem Cell and Gene Technology in Hanoi, Vietnam from 2016 to 2020

Eligibility Criteria:
Inclusion Criteria:

* The patient who was diagnosed with lumbar spina bifida underwent spinal cord close-up surgery.
* Both genders.
* Aged between 6 months and 15 years old.
* Exhibited bowel disorders (constipation, fecal incontinence) and urinary dysfunction (urinary retention or leakage).

Exclusion Criteria:

* Vertebrae clefts in the chest, neck, and other spinal locations.
* Coagulopathy.
* Acute and chronic infection.
* Kidney function disorder, liver failure
* Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
* Distress
The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients

The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns.

The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain.

The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.

Design: Prospective, case control Setting: subjects will undergo a tailored training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms (APOS system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel) which conveys perturbation throughout the gait sickle. Pre and post training level walking will be examined via: (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 4 different settings Patients will then participate in continued biomechanical perturbation training for 3-6 month and will then undergo a second gait examination Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: None Accepts patients suffering from medial compartment knee osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Community-dwelling older adults.
  2. Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale.
  3. Ambulatory and active patients that can precipitate the gait analysis.
  4. Age 50-75.
  5. No prior joint replacement in the lower extremity.

Exclusion Criteria:

* Exclusion Criteria:

  * Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.
  * Knee with flexion contracture greater than 20°.
  * Patients with hip problems, symptomatic lumbar spine disease, spinal cord.
  * Ataxic gait related to neurologic disease.
  * Patients with increased tendency to fall.
  * Lack of physical or mental ability to perform or comply with the treatment procedure.
  * Diabetes mellitus.
  * History of pathological osteoporotic fracture.
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk

Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Opeation Pty Ltd.

The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the end of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with 0% in the vehicle group.

The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005 Topical Gel, in patients, when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

Eligibility Criteria:
1. Male or female patients at least 18 years of age.
2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass
3. Ability to follow study instructions and likely to complete all study requirements.
4. Written informed consent has been obtained.
5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.
Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy

The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy.

The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.

Randomized controlled intervention study

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of patellar tendinopathy
* Symptoms \> 3 months
* Pain localized to the inferior pole of the patella
* Victorian Institute of Sport Assessment (VISA) score less than 80 points
* Palpation tenderness of the patellar tendon
* Abnormal tendon (hypoechoic) confirmed by ultrasonography.

Exclusion Criteria:

* Previous knee surgery
* Confounding diagnosis to the knee joint
* Previous corticosteroids injections
* Arthritis or diabetes
AGIR Study: Angio-Seal in Interventional Radiology

Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access.

It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.

Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression.

Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week).

The randomization will be stratified according to the type of procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)
* Patient available for follow-up at 2 weeks
* Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.

Exclusion Criteria:

* Access unsuitable for use of Angio-Sea
* Presence of calcification at the puncture site
* Presence of visible hematoma at the end of the procedure
* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
* Patients who are pregnant.
* Patients currently participating in a clinical investigation that includes an active treatment arm.
* Contraindication for ambulation at 2 hours after the end of the procedure
* Patients with a life expectancy of less then 1 month.
Dietary Variety Versus Dietary Fat Effects in Energy Intake

The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.

We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood.

The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.

We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood

Eligibility Criteria:
Inclusion Criteria: Healthy adults age 18-5 y with BMI 20-35 kg/m
MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery

This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for one or two level lumbar spine surgery requiring an inpatient stay as well as patients having ambulatory 1 or 2 level lumbar spine surgeries
* PCS score ≥ 20
* Able to provide voluntary informed consent
* Telephone access
* Internet access

Exclusion Criteria:

* Non-English speaking
* Cognitively impaired, by history
* Bipolar disorder
* Borderline personality disorder
* Active post-traumatic stress disorder
* Schizoaffective disorder or any other disorder characterized by delusions or hallucinations
* History of self-harm or suicidality in past three months
Investigation of GLP-2 Mechanism of Action (GA-8)

Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit the bone resorption. However, the mechanism is unknown. In the present study we will investigate the mechanism of action using a receptor specific inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, 20 to 40 years old, caucasian, BMI 18,5 to 24,9 kg/m2

Exclusion Criteria:

* Chronic disease, smoking, medication, weight change more than 3 kg whitin the last 3 months, overweight surgery, intestinal surgery, Hgb\<8,0 mmol/L, decreased renal function.
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults.

Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events

Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* High concerns or high risk of fall
* Ambulatory

Exclusion Criteria:

* Presence of an active wound infection on either of the foot and ankle
* Use of medication or a medical condition that may have unstable (fluctuate over time) or temporary (less than one month) impact on gait and balance
* Acute fractures on the foot
* Participant of an interventional study within the last 30 days
* Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m (\~six feet) without assistance
* Major foot amputation
* Unable or unwilling to participate in all procedures