cyrilzakka/clinical-trials huggingface dataset:
Relationship of the Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation

Overall objective: To analyze the relationship of the physical activity practice measured directly with the autonomic cardiac modulation in adults. Specific objectives: i) to verify through the Baecke questionnaire whether the different domains of physical activity (work, leisure and occupational activities) are related in the same way to the autonomic cardiac modulation; ii) Analyze whether high blood pressure and resting heart rate values are related to poor cardiac autonomic modulation regardless of nutritional status.

Cardiovascular disease is a major public health problem and has contributed to a high mortality rate in the adult population. One of the precursors of these diseases is low cardiac autonomic modulation. Thus, factors that may be related to greater cardiac autonomic modulation should be investigated with the aim of preventing cardiovascular diseases. One of these factors that may contribute to increases in cardiac autonomic modulation is the practice of physical activity. However, the studies investigating this relationship have been controversial, generally evaluating the practice of physical activity in a subjective way, and there is no clarity as to whether the different domains of physical activity would be related differently to cardiac autonomic modulation. Overall objective: To analyze the relationship of the physical activity practice measured directly with the autonomic cardiac modulation in adults. Specific objectives: i) to verify through the Baecke questionnaire whether the different domains of physical activity (work, leisure and occupational activities) are related in the same way to the autonomic cardiac modulation; ii) Analyze whether high blood pressure and resting heart rate values are related to poor cardiac autonomic modulation regardless of nutritional status. Implications: The results of this study will contribute to clarify the relationship between physical activity practice and cardiac autonomic modulation considering a large sample of subjects (n = 252), as well as whether the different domains of physical activity are related to autonomic modulation cardiac. These results may help in the elaboration of health promotion strategies.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* be resident of the city of Anastácio-SP (Brazil)
* sign the informed consent form

Exclusion Criteria:

* use less than 5 valid accelerometer days
* present an error in heart rate variability greater than 5%
Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy

The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.

Group of patients using the same aromatase inhibitor

Eligibility Criteria:
Inclusion Criteria:

Patients with endocrine responsive early stage postmenopausal breast cancer. Patients who received tamoxifen for 2-3 years as adjuvant endocrine therapy. Patients who were approved to switch to aromatase inhibitor treatment during the patient recruitment period.

Patients who were informed about the study and accepted to participate.

Exclusion Criteria:

Patients having a psychological disorder which will prevent their understanding of questionnaires used for evaluation of quality of life and / or patients who are illiterate.
Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA)

The object of this study is to evaluate whether low dose intravenous iron and erythropoietin (Epo) can decrease transfusion requirement after the bilateral TKRA.

Total knee replacement arthroplasty (TKRA) in severe osteoarthritis usually requires extensive soft tissue and bone dissection associated with substantial bleeding. Because TKRA is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial, however, over 80% of the total blood loss occurs within the first 24 hour after the operation and the hidden blood loss is 50% of the total loss, making the true blood loss twice. Consequently, many patients can become anemic at early postoperative period and this anemic condition may lead to overall physical deterioration which include fatigue, dizziness, reduced exercise tolerance and delayed recovery.

Therefore, many patients frequently received the autologous or allogenic blood transfusion. In order to reduce the allogenic blood transfusion (ABT), various methods have been used, such as preoperative autologous blood donation (PABD), use of pharmacologic agents, iron or erythropoietin (Epo) and postoperative blood salvage. All of the above methods have been proved to reduce the ABT effectively6, without increase in cost.

Iron and Epo have been used widely in a variety of clinical situations instead of allogenic RBC transfusion. They also have been used for augmenting PABD or improving preoperative hemoglobin (Hb) level. However, there still remains a controversy about the efficacy of the method on the postoperative anemia. We think that these various results may be related with individual iron state of the patients and dose of drug or timing of drug application.

In this trial, iron and Epo are planned to be administered to the iron deficient non anemic patients during the operation and once again after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing bilateral total knee replacement arthroplasty
* American society of anesthesiologist class 1-3
* Hb\>100 g/L
* Either serum ferritin\<100 ng/ml or 100\<ferritin\<300 ng/ml with a transferrin saturation (TSAT) \<20%

Exclusion Criteria:

* Hematologic disease
* Thromboembolic disease
* Hepatic or renal disease
* Coagulation disorder
* Infection
* Malignancy
* Under anticoagulant therapy
* Hypersensitivity to iron sucrose or Epo
* Preoperative autologous blood donation
* Use of iron or Epo and blood transfusion within the previous 1 month
Colchicine and CRP in Atrial Fibrillation and AF Ablation

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

1. Paroxysmal atrial fibrillation, pre-ablation
2. Persistent atrial fibrillation, pre-ablation
3. Chronic persistent atrial fibrillation

Eligibility Criteria:
Inclusion Criteria:

* Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
* Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
* Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .

Exclusion Criteria:

1. Abnormal liver function with elevated enzymes\> 1.5 times the normal.
2. Abnormal kidney function with glomerular filtration rate \< 50 ml/min
3. Increased levels of creatine kinase or known myopathy
4. Neutropenia
5. Known GI disorders
6. Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.
7. Pregnant and lactating women
8. Lactose intolerance
9. Known sensitivity, allergy, or contraindication to colchicine use
Foot Self-care in Older Adults

This pilot study will make a preliminary evaluation of the efficacy of 2 Feet 4 Life, a foot care self-management program, on foot care knowledge, foot care self-efficacy, foot care behaviors, and foot pain in community dwelling older adults without diabetes mellitus.

One in three older adults have foot problems such as bunions, corns, calluses, foot pain, or nail disorders, but those problems are often ignored or overlooked until they threaten mobility or quality of life. With proper self-management, skin and nail problems can be addressed before they become severe; however, older adults without diabetes are not routinely informed of self-management techniques unless they consult a specialist. Targeting a foot care self-management program to community-dwelling older adults without diabetes may not only enhance foot function and preserve independence but also reach older adults with limited healthcare access.

Study participants will be 24 nondiabetic older adults recruited from two Midwestern community senior centers. One community center will be randomized to receive the intervention, 2 Feet 4 Life, the other will be a true control group receiving no intervention. The 2 Feet 4 Life foot care self-management program is based on Social Cognitive Theory and will be delivered in four weekly, one-hour group sessions. The program includes self-management teaching, interactive lecture, and group activities, including instruction, demonstration, and practice of routine foot care. In addition to usual lecture and handouts, 2 Feet 4 Life will rely on group interaction, practice opportunities, and the provision of foot care supplies so participants can perform foot care at home. Program topics include appropriate foot hygiene and footwear, identification and treatment of common foot problems, demonstration of proper foot care with opportunities for practice and instructor feedback, and guidance in obtaining appropriate footwear.

Outcome measures will be assessed pre-intervention, immediately post-intervention, three months post-intervention, and six months post-intervention. This will be the first study to test a nurse run, community-based, foot care self-management program for non-diabetic older adults.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* legally competent to sign informed consent
* willing to participate in the study

Exclusion Criteria:

* self-reports of diabetes
* non-traumatic amputation
* legal blindness.
* demonstrated inability to see and remove dot stickers on the feet
* active ingrown toenails
* absent pedal pulses
* poor sensation as defined by the inability to feel more than 3 of 10 foot sites touched with a microfilament
* regular visits to a healthcare professional for foot care
* score of \<2 on the mental status screener.
Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19

Mortality from Covid-19 increases with age, reaching 14.8% from the age of 80. The severity of the infection is linked to the acute respiratory distress syndrome (ARDS) which requires intensive care. ARDS is the consequence of the reactional inflammatory storm that damages the lungs.

Aged subjects are particularly prone to zinc and vitamin D deficiency. These two micronutrients are able to modulate the immune response by reducing the inflammatory storm.

The hypothesis is that supplementation with zinc and vitamin D would reduce the inflammatory reaction which worsens ARDS and leads to the death of subjects infected with Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized

Exclusion Criteria:

* Life expectancy \< 1 month independently of Covid-19 infection (overall subjects)
* Known hypercalcemia
* History of renal lithiasis
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion

A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study

Exclusion Criteria:

* NA
Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
* Resides in the United States
* Endorses less bloating or indigestion as a primary desire
* Has the opportunity for at least 20% improvement in their primary health outcome score
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* The calculated validated health survey (PRO) score during enrollment represents less than mild severity
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in another clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with macular edema resulting from retinal vein occlusion
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin
Brain Tumor Treatment Satisfaction Survey

Patients with recent diagnosis and treatment of a brain tumor will complete a short questionnaire concerning the patient's quality of life and emotional state since receiving treatment. Caregivers will complete a one-page questionnaire concerning the patient's quality of life and emotional state since receiving treatment.

Patients with a recent diagnosis and treatment of a brain tumor (primary or metastatic; N=105, 61% female, 39% male) were identified in the clinics of Semmes-Murphey Neurologic and Spine Institute or the Methodist University Hospital in Memphis, TN. Caregivers were recruited from among relatives and friends who provide the most day-to-day care to the patient. All participants were between 3 months and 1 year from their most recent brain tumor treatment. Participants were given a simple, 5-point based survey to asses treatment-specific satisfaction, patient education, posttreatment quality of life, and pre- and post-treatment emotional impact. Therapeutic modalities surveyed include: surgery, external beam radiotherapy, whole-brain radiotherapy, stereotactic radiosurgery, and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 3 months and one year out from treatment for their brain tumor
* Karnofsky Performance Status (KPS) \>= 60
* Age 18 years or over, any gender, any race
* "patient caregivers will be individuals who provide the most day-to-day care for their respective brain tumor patients

Exclusion Criteria:

* No exclusions
Retroversion in Reverse Shoulder Arthroplasty

The goal of this clinical trial is to compare function in reverse shoulder arthroplasty (RSA) using two different degrees of humeral retroversion (RV). The main question it aims to answer is:

• Does external rotation improves when using a higher retroversion?

Participants will randomly receive a 0 degree or 30 degree RV for their RSA.

They will be followed for two years and clinical outcomes will be recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 60 years
* primary rotator cuff arthropathy
* implantation of reverse shoulder arthroplasty

Exclusion Criteria:

* previous surgeries in the shoulder
* post-traumatic arthropathy
Surveillance of Summer Febrile Syndromes of Viral Origin in South of France

The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.


Eligibility Criteria:
Inclusion Criteria:

* Old: equal to or higher than 5 years Living in the south of France, without voyage abroad in the 2 weeks preceding inclusion Presenting a fever or a syndrome pseudogripal since less than 7 days without diagnostic orientation nor infectious pathology of body,
* Affiliated with a mode of social security
* After obtaining free and informed of the written assent

Exclusion Criteria:

* Subject whose adhesion with the protocol is improbable according to the investigator
* Expectant mother
* Subject taking part in another clinical trial or in period of exclusion of a preceding clinical trial infectious
* Pathology of body requiring a specific treatment
* Discovered after inclusion d' a pregnancy
Detection of Bone Marrow Changes: Comparison of MRI and DECT

Prospective study where magnetic resonance imaging is compared to dual-energy computed tomography for the detection of bone marrow changes.


Eligibility Criteria:
Inclusion criteria:

* Patients with bone marrow changes

Exclusion criteria:

* Pregnacy
* Age below 18 ys old
* Contraindications for MRI
Geko™ KM40C Hydrogel Skin Adhesion Trial (XW-3)

Hydrogel KM40C is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ XW-3 neuromuscular electrical stimulation (NMES) device. KM40C has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. KM40C has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ NMES treatment as an adjunct to standard care for wound management.

The objective of this trial is to evaluate the skin adhesive performance of hydrogel KM40C during clinical use of the geko™ XW-3 NMES device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel KM40A incorporated in the self-adhesive geko™ W3 device which is currently in use clinically. Both devices are indicated for use to promote wound healing, the geko™ W3 NMES device is UKCA and CE marked whereas the geko™ X-W3 is UK CA marked only.


Eligibility Criteria:
Inclusion Criteria:

1. Adult over 18.
2. Patients who have a lower limb ulcer following evaluation by a Tissue Viability Nurse Specialist
3. Intact healthy skin at the site of geko™ device application.
4. Willing and able to give written informed consent
5. Identified to receive geko™ treatment as an adjunct to standard care for wound management.

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Use of any other neuro-modulation device.
3. Use of a cardiac pacemaker
4. Current use of TENS in the pelvic region, back or legs
5. Contraindication to geko ™ NMES treatment
6. No response to geko ™ NMES i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
7. Participation in any other clinical trial that may interfere with the outcome of either trial.
Dynamic Splinting After Total Knee Arthroplasty

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.

The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Reduced flexibility in AROM of knee extension
* Pain that is worsened by bending over while legs are straight
* Impaired gait pattern
* Ability to understand informed consent and experiment responsibilities

Exclusion Criteria:

* Fractures
* Knee sepsis
* Osteomyelitis or any orthopedic infection
* Extensor mechanism dysfunction
* Psoriasis
* Knee joint neuropathy
* Previous Stroke or Brain Injury