cyrilzakka/clinical-trials huggingface dataset:
High Intensity Interval Training and Hypoxic Conditioning in Obese Patients

The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.

120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 27 and 35 kg/m²
* Physical activity \<2 hours/week
* No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity

Exclusion Criteria:

* Diabetes mellitus treated with insulin
* Auto-immune or inflammatory diseases requiring long term therapy
* Unstable dysthyroidism
* Bariatric surgery within the past 18 months
* Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease
* Untreated sleep apnea
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis

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Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
* Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.

An eligible subject must have:

* Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
* Must have vision ≥ 20/40 in the non-study eye.
* Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.

Exclusion Criteria:

* Any form of infectious uveitis
* Active retinitis
* Cancer or melanoma that is actively treated with immunotherapy
* Pregnancy / lactation
* Receiving specific medication/interventions as specified per protocol
Novel Wearable Device for Heart Failure Management

Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.

The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.

The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HF ≥ 3 months
2. Diagnosis of NYHA Class III HF
3. Subjects with age ≥ 18 years
4. At least 1 HF hospitalization within 12 months prior to enrollment
5. Subjects with elevated ambulatory levels of BNP/NT-proBNP

Exclusion Criteria:

1. Subjects unable to cooperate to complete the trial.
2. Subjects with severe arrhythmia.
3. Subjects with cardiac shock.
4. Subjects with acute myocardial infarction.
5. Subjects with local skin infections and injuries in the jugular vein area
6. Subjects with active uncontrolled infections
7. Subjects with eGFR \< 25 mL/min/1.73m2
8. Pregnant women, or women likely to undergo pregnancy
9. Subjects with life expectancy less than 6 months
PRESERVE-Zenith® Iliac Branch System Clinical Study

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* An aortoiliac or iliac aneurysm of appropriate size
* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

The investigators hypothesize that surgical release of the filum terminale (strand of fibrous tissue at the end of the spinal cord) is a more efficacious treatment option for symptomatic relief than medical management in subjects with Occult Tethered Cord Syndrome (OTCS) and that the risks do not outweigh the benefit profile.

This is a phase II pilot randomized-controlled, single-site trial to determine if surgical untethering of the filum terminale is more effective, preliminarily, than medical management as a treatment option for OTCS. Subjects will be randomized to one of two arms: surgical untethering or medical management only. Symptom improvement and adverse events will be assessed and recorded for 1 year from initiation of treatment. After a minimum of 1 year, subjects who were randomized to the medical management arm may cross over to the surgical arm if the PI deems it is in the subject's best interest to do so. The exploratory hypothesis is that surgery for OTCS is both safe and more effective than medical management at relieving the symptoms of OTCS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 2 and \< 80 years of age.
* Refractory to medical management of symptoms for at least 1 year.
* Documentation of OTCS, as defined by a total score of at least 30 on the following scale:

OCCULT Grading Scale (Score 0-100) Orthopedic Abnormality: 0-15; Central Nervous System Dysfunction: 0-25; Cutaneous Stigmata: 0-10; Urological or Bowel Dysfunction: 0-25; Lumbosacral Anatomy: 0-15; Tissue Integrity Disorder: 0-10.

Exclusion Criteria:

* Subjects \< 2 or \> 80 years of age.
* Radiographically identified tethered cord, as defined by any of the following:

  * A low-lying conus (at or below the L2-3 disc space)
  * A thickened filum (\>2 mm)
  * Fat in the filum or lipoma
  * Distinct adhesion or tethering.
* A history of Meningocele manqué or Myelomeningocele.
* Cutaneous markings of dermal sinus tract.
* History of prior surgery on the lumbar spine.
* History of prior surgery for spinal dysraphism.
* History of prior infection or autoimmune condition of the central nervous system.
Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa

Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.


Eligibility Criteria:
Inclusion Criteria:

* This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in KwaZulu Natal, South Africa, who have no prior history of HPV immunization. We have selected fifth graders for our target population to follow the current Provincial Guidelines. This is in line with National Cervical Guidelines aimed at reaching young people prior to their sexual debut.

We will also be recruiting parents/caregivers of these children, given their role in decision-making. All parents/caregivers will be at least 18 years old. We will also be including adults who are at least 18 years of age, who are employed at participating schools as teachers or school administrators, and others who are engaged in the planning or implementation of the school-based HPV vaccine program (e.g., representatives from the Department of Health, nurses). We have no upper age limit for this population.

Exclusion Criteria:

* Children below the age of 9 years old will not be included in the study.
Health Promotion on Young Adults With High Risk Disability for Mental Health

1. The positive outcomes reported by participants in experimental group after two weeks of interventions will be significantly better than before interventions.
2. The positive outcomes reported by participants in experimental group will be significantly better than those in control group after two weeks of providing prevention model interventions.
3. The positive outcomes reported by participants in experimental group will be significantly better than those in control group after six months of providing prevention model interventions.

Early finding for people with high mental risk plays the important role in mental health promotion. In literature, before specific psychotic symptoms appear, individuals may experience a period of nonspecific symptoms and growing functional impairment. Early interventions may alter the natural course of mental diseases and improve treatment outcomes. So that, the purpose of this study is to develop a screen and prevention mode for identifying young adults with high risk status of mental health disability. The psychosocial intervention strategies for emotional and cognitive support in prevention model based on health promotion theory will be used for this study. Participants in this experimental design study will be randomly assigned into experimental and control groups. Four scales and objective physical assessments are used for evaluating study outcomes. The pre- and post-test will be held before and one week after prevention interventions. In addition, follow-ups will be included for understanding long-term outcomes of the effectiveness of the screen prevention model.

Eligibility Criteria:
Inclusion Criteria:

* age 20-65 years, (Chinese version of Schizotypal Personality Questionnaire-Brief \> 17 scores, or Chinese Mandarin State Trait Anxiety Inventory Y2 \> 60 scores), and agree to participants.

Exclusion Criteria:

* had been diagnosed as schizophrenia, bipolar disorders, and major depression.
Smart Technology for Weight Loss and Metabolic Health

The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese BMI 25-42 kg/m2
* Employed in sedentary occupations
* Own a personal smartphone with unlimited data plan or \>4 GigaByte data
* Proficient with use of smartphone applications and technology with current daily usage
* Ability to engage in moderate intensity exercise
* Weight stability for the last 2 months
* Participants must be willing to comply with all study-related procedures

Exclusion Criteria:

* Current or planned pregnancy
* Cardiovascular, pulmonary, renal disease, joint disease
* Uncontrolled thyroid disease
* History of eating disorders, psychiatric disease
* History of substance abuse or dependence in the last 1 year
* Diabetes
* Shift work
* Previous weight loss surgery
* Use of weight loss drugs/diet/program in the last 6 weeks
* Inability to increase walking as a form of exercise and to engage in moderate intensity exercise
* Other conditions or medications that affect body weight/appetite/metabolism
* Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
* Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
Iron Indices and Intravenous Ferumoxytol: Time to Steady State

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days
* TSAT less than or equal to 25 percent
* Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)
* (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)
* Subjects who are able to read and write in English
* Subjects who have signed consent

Exclusion Criteria:

* Subjects who have been enrolled in a clinical trial within the past 30 days
* Subjects who have received IV iron within 4 weeks of the start of the study
* Serum ferritin greater than or equal to 1200 ng/dL
* Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL
* Evidence of iron overload
* Known hypersensitivity to ferumoxytol or any of its components
* Anemia caused by conditions other than iron deficiency
* Subjects with elective surgeries scheduled within the next 3 months
* Subjects with elective magnetic resonance procedure scheduled during the study period
* Subjects who have been hospitalized within the past 30 days (excluding vascular access care)
* Subjects who have received a blood transfusion in the past 30 days
* Subjects who are transfusion dependent
* (Female) Subjects who are pregnant or nursing
* Subjects with known inflammatory conditions which may affect serum ferritin
* Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)
* Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)
* Subjects with life expectancy less than 6 months
* Subjects who refuse to sign consent
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test

Aim: This research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the COVID test.

Inroduction: In the literature review, it has been seen that the positive effect of different nanpharmacological methods is supported to reduce pain and anxiety caused by medical procedures. Non-pharmacological methods are classified as physical methods, cognitive behavioral methods, and environmental or emotional intervention methods. In order to draw attention to another direction, which is among these methods; watching cartoons, inflating balloons, creating balloons by blowing foam, talking about things unrelated to the initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction cards etc. is located. The subject of the study is the application of distraction methods in reducing the pain associated with short-term medical interventions.

Eligibility Criteria:
Inclusion Criteria:

* children who will be taken samples for Covid 19 test
* being between the ages of 5 to 10 years,
* literate

Exclusion Criteria:

* having chronic diseasesvisual
* audio, or speech impairments
* mental disorders,
* history of sedative, analgesic, or narcotic use within 24 h before admission
* inflammatory disease during admission.
Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1006. In this prospective one-arm observational study, bone scintigraphy will be performed in T1N0M0 NSCLC patients with GGO lesion and other low risk factors of bone metastasis. The occurrence rate of bone metastasis in these patients will be analyzed to evaluate the necessity of bone scintigraphy in cT1N0M0 NSCLC patients.

Skeletal is a common metastatic site in patients with non-small cell lung cancer. The incidence of bone metastases is about 20-30％ in NSCLC patients. According to the NCCN guidelines, early lung cancer patients should also undergo bone scan or PETCT before surgery to determine the presence of bone metastases. However, all of the above methods use radionuclide reagents as tracers, which pose health hazards to patients and their contacts, including medical personnel. A retrospective study conducted by our center showed that only 0.95% of patients with cT1N0M0 non-small cell lung cancer had preoperative bone metastases. In patients with early stage lung cancer whose lesions are pure ground glass nodules, the probability of developing bone metastases is zero. The low risk factors for bone metastases from this retrospective study included preoperative examination of patients with CEA \<5 ng/ul and no bone-related symptoms. In patients with primary NSCLC who underwent CEA \<5 ng/ul preoperatively, no bone metastases occurred; in patients with negative bone-related symptoms, the incidence of bone metastases was only 0.18%. In the case of such patients, if the bone scan is performed, not only the potential damage to the patient is increased, but also the waste of medical resources and the burden on the patient from the perspective of health economics.

Therefore, our center is expected to conduct this prospective one-arm observational clinical trial. According to the low-risk factors derived from retrospective studies, bone scintigraphy was performed in patients with GGO lesion and other low risk factors of bone metastasis, and the incidence of bone metastasis was obtained. The necessity of bone scintigraphy in cT1N0M0 NSCLC patients would be evaluated.

This trial is recognizes in our institute as "Eastern Cooperative Thoracic Oncology Project (ECTOP-1006)"

Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Age 18-80 years old;
3. ECOG score ≤ 2 points;
4. CT shows that the main lesion is considered to be ground glass nodular lung cancer;
5. Preoperative examination CEA \<5ng/ul
6. There are no bone related symptoms
7. There is no obvious absolute surgical contraindication for preoperative examination.

Exclusion Criteria:

1. History of bone related diseases.
2. History of other kinds of cancer
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy

Exclusion Criteria:

* Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects

This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.

Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT, glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry will be measured before and 3 months after the NSPT.

Eligibility Criteria:
Inclusion Criteria:

* Chronic periodontitis
* Non diabetic individual

Exclusion Criteria:

* Known diabetes
* Periodontal treatment less than 6 months prior to inclusion
* Having less than 20 natural teeth