cyrilzakka/clinical-trials huggingface dataset:
Home Exercise Intervention in Persons With Multiple Sclerosis

The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with Multiple Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.

This study will use a two-arm randomized control trial (RCT) design to examine the effect of a home-based exercise training program versus a minimal exercise, attention control condition on markers of subclinical atherosclerosis and mobility disability in persons with MS. The primary outcomes will be subclinical atherosclerosis including measures of arterial structure and function and measures of mobility disability including the six-minute walk and timed 25-foot walk, GaitRite walking assessment and one week of accelerometry data.

Fifty-four persons with MS who have an Expanded Disability Status Score (EDSS) score between 0 and 4.0 will be randomized into either the home-based exercise training condition or the attention control condition. Participation in this study will include a 3-month exercise program to be completed at home. In addition, participants will need to come to University of Illinois at Chicago (UIC) three times to undergo testing. Each visit will take about 3-4 hours to complete. Testing that will take place during these three visits include blood pressure measurement, six vascular (artery) measurements, heart measurements, short walking tests, peak aerobic capacity test, blood draw, five quality of Life questionnaires and two cognitive function tests.

The home-based exercise regimen will include cycle ergometry as an aerobic mode of training 3 times per week with a gradual progression of duration and intensity across a 12-week period. Exercise prescription will be based on the peak aerobic capacity cycling test conducted during the first visit. The attention control will involve stretching using the same frequency and duration across a 12-week period with exercises recommended by the National Multiple Sclerosis Society (NMSS). Both arms will receive weekly internet "coaching" sessions via video chatting.

Subclinical atherosclerosis and mobility disability data will be collected before, after 6 weeks of training and immediately after the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* physically inactive
* BMI\<40
* 1st stage of MS (i.e., defined as EDSS score of 0 - 4.0)
* independently ambulatory (walking without an assistive device such as a cane or orthotic)
* relapse free in the past 30 days
* confirmed diagnosis of MS
* asymptomatic (i.e., no underlying clinically diagnosed cardiovascular disease)
* be on a stable disease modifying therapy
* physician approval for undertaking exercise testing and training
The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia

The purpose of this study is to examine whether the intraocular pressure of operated people under general anesthesia is affected by the artificial respiration method. If it is proven that there is such influence, the findings may lead to select the best method for patients with increased intraocular pressure.

In this study, the investigators will monitor the changes observed in intraocular pressure caused during an operation in two different artificial respiration methods:

1. Intermittent positive pressure ventilation (IPPV)
2. High frequency jet ventilation (HFJV)

Study recruited 50 patients aged 18 - 40, candidates to elective orthopedic surgery in the limbs. These patients do not suffer from general diseases that restrict their daily functioning.

The selection of the type of surgery was done to prevent the involvement of any other factor, except the respiration method, determination of intraocular pressure.

Exclusion Criteria:

* Patients who are unable to provide an Informed Consent
* Patients suffering from any eye disease
* Patients with corneal thickness less than 450 microns or more than 600 microns
* Smokers
* Patients with pulmonary disease restrictive or obstructive
* Patients using bronchodilator

All patients operated under general anesthesia using total intravenous anesthesia )TIVA) method.

All patients will be resuscitating half of the time of surgery using IPPV, and in the second half of surgery using HFJV.

During the surgery the IOP will be measured by an ophthalmologist who is unaware of the respiration method.

Correction will be made to the intraocular pressure values, depending on the thickness of the cornea.

The results of the measurements will be collected and the clinical significance will be reviewed by acceptable statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 40
* Patients candidates to elective orthopedic surgery in the limbs
* Patients do not suffer from general diseases that restrict their daily functioning.

Exclusion Criteria:

* Patients who are unable to provide an Informed Consent
* Patients suffering from any eye disease
* Patients with corneal thickness less than 450 microns or more than 600 microns
* Smokers
* Patients with pulmonary disease restrictive or obstructive
* Patients using bronchodilator
Genetic and Environmental Determinants of Hypertension

To determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension.

BACKGROUND:

Essential hypertension is believed to be a heterogeneous group of disorders, the subtypes of which could be related to sodium sensitivity, obesity, diabetes, calcium intake and metabolism, the renin-angiotensin balance, or membrane cation transport. Essential hypertension aggregates in families. The syndromes leading to hypertension may involve shared genes, shared environmental factors, or both.

DESIGN NARRATIVE:

In 1980 a series of biochemical and physiological tests were initiated in the 2,548 persons in 98 extended pedigrees in Utah. Most of the subjects were obtained from three major pedigree types: stroke cluster pedigrees; coronary heart disease cluster pedigrees; and pedigrees of Utah Hypertension Detection and Follow-up Program high blood pressure probands. Data were collected on personal history, medical family history and genealogy, anthropometrics, standard and 32-lead electro- cardiograms, multiple blood pressure measurements during sitting, standing, lying, tilting, isometric hand grip exercise, bicycle exercise, venipuncture and mental arithmetic. Cation tests included sodium-lithium countertransport, lithium-potassium co-transport, intracellular sodium, potassium, magnesium, sodium-potassium ATP-ase pump activity and binding sites and plasma levels of sodium, potassium, magnesium, ionized calcium and digoxin-like pump inhibitor. Information was also collected on stress, exercise, plasma renin activity, and urinary kallikrein. Statistical and pedigree analysis were conducted.

The same tests were also performed on 600 new population-based hypertensive subjects on drug therapy and again four months after interruption of drug therapy. Tests were conduced for specific subtypes of high blood pressure among the 600 subjects using individual variables and multivariate combinations of variables. Three hundred nuclear families were screened to test for familiality of subtype indicators and to identify those high blood pressure subtype indicator variables needing detailed pedigree analysis.

One thousand sequentially-sampled persons were studied for major genes, DNA probe linkage, and gene-environment interactions as determinants of specific types of hypertension.

Eligibility Criteria:
No eligibility criteria
The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation

This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation


Eligibility Criteria:
Inclusion Criteria: patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019 -

Exclusion Criteria: None.

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Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between and including 18 and 45 years at time of Visit 1
2. Subjects willing to give written informed consent to participate in the trial
3. Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

Exclusion Criteria:

1. Subjects unwilling to give his/her consent to participate in the trial
2. Subjects who have received Typhoid containing vaccines
3. Subjects who have past history of Typhoid
4. Subjects already immunized with any licensed vaccine within 4 weeks
5. Subjects with known hypersensitivity to any component of the study vaccine
6. Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
7. Subjects with any abnormality or chronic disease
8. Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
9. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
10. Subjects who have known history of immune function disorders
11. Subjects who have known history of administration of blood or blood-derived products
12. Subjects who have history of alcohol or substance abuse
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers

The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-praliciguat.


Eligibility Criteria:
Inclusion Criteria:

* Males of any race, between 18 and 55 years of age, inclusive
* Body mass index between 18 and 32 kg/m2, inclusive
* Subject is in good health and has no clinically significant findings on physical examination
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Use of any prescribed or non-prescribed medication

Additional inclusion/exclusion criteria may apply per protocol
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease

The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.

A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) results in de novo or restenotic atherosclerotic renal artery stenoses.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure \>160/90

Exclusion Criteria:

* Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency
Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms

The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe for the treatment on health-related quality of life in Parkinson's disease (PD) patients with gastrointestinal symptoms.

Gastrointestinal (GI) symptoms are frequently complained by PD patients. To improve their symptoms, prokinetics are often used in clinics. However, some prokinetics are dopamine receptor antagonist which can aggravate motor symptoms of PD patients or develop tardive dyskinesia when it affects dopamine receptors of the brain.

DA-9701 (Motilitone) is recently developed herbal medication which has both 5-HT4 agonism and D2 antagonism. Furthermore, it does not cross the blood brain barrier that can be safely used in PD patients. Hypothetically it has a potential to be a good choice for the treatment of GI symptoms of PD patients. However, there has been no study that evaluates its efficacy and safety by randomized clinical trials in PD patients.

This study will evaluate the efficacy and safety of DA-9701 in the double-blind placebo-controlled phase 1 (4 weeks), and the long-term safety of DA-9701 in the open-label phase 2 (8 weeks after phase 1).

Eligibility Criteria:
Inclusion Criteria:

* Subjects were enrolled voluntarily and understood the contents of this clinical trial.
* Male or female Parkinson disease (PD) patients between 50 and 80 years
* Subjects who had not received prokinetics (itopride, mosapride, Corydalis tuber, levosulpiride, domperidone, etc.) at least 2 months prior to baseline visit
* Subjects complained at least one symptom of the following that suggests abnormal bowel functions: anorexia, nausea, abdominal distension, dyspepsia, early satiety, dysphagia, foreign body sensation associated with a meal, symptoms of gastroesophageal reflux, constipation, and defecation problem.

Exclusion Criteria:

* History of a gastrointestinal operation
* Subjects with active gastrointestinal diseases under treatment of gastroenterology within 1 month
* Existence of clinically significant cognitive decline or K-Minimental Status Exam score 20 or less
* Subjects had depression or other psychiatric disorders treated with medications such as antidepressants or antipsychotics; mood tranquilizers, benzodiazepines, and sleep pills were permitted with fixed dose during a period of the clinical trial
* Subjects with severe active comorbidities which could interfere the quality of life of the patient
* Subjects with medical conditions which make difficult to be enrolled to the trial judged by clinicians
* Subjects with hypersensitivity or adverse event related to DA-9701 (Motilitone)
* Prior participation to other clinical trials within 3 months
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the posterior maxilla is a safe and predictable procedure.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Aged 20-75 years at enrollment
3. History of edentulism in the posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
4. Neighboring tooth to the planned bridge must have natural root.
5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
7. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Earlier graft procedures in the study area
3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
4. Uncontrolled pathologic processes in the oral cavity
5. Known or suspected current malignancy
6. History of radiation therapy in the head and neck region
7. History of chemotherapy within 5 years prior to surgery
8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
9. Uncontrolled diabetes mellitus
10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
11. Smoking more than 10 cigarettes/day
12. Present alcohol and/or drug abuse
13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
14. Previous enrollment in the present study.
15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
16. Subjects that are unable to give informed consent
GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit

The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland.

Methods:

Citizens of Greenland above the age of 18 years referred for cystoscopy will be invited to participate in an observational study at the time of already planned cystoscopy.

Hypothesis:

The investigators hypothesize that the Xpert® Bladder Cancer Detection test can identify patients with a bladder tumor and serve as a future selection tool to support clinical decision whether to perform a cystoscopy or not - especially in areas with limited access to urological services.

Perspectives:

The investigators hope to improve the current poor prognosis for bladder cancer patients in Greenland with the early detection. If this is successful, it could change the way patients are examined for bladder cancer in Greenland, but in the long term also in Denmark and other countries. Thus, the study will be able to determine whether a simple urine examination should be introduced early in the current cancer program in order to reduce the number of patients who need to undergo a cystoscopy and who can avoid this and get an earlier clarification.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at the time of signing the Informed Consent Form with an indication for cystoscopy and planned for this already at study inclusion.
* Ability to understand the Participant Information Sheet orally and in writing in either Danish or Greenlandic.
* Signed Informed Consent Form.
* Is, according to the Investigator's judgement, able to comply with the trial protocol.

Exclusion Criteria:

* Patients not willing to participate.
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool.

Complementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (\<3% complications) but of limited sensitivity in cases of nodules \< 20 mm.

The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity

Tumor biopsy is often required to characterize indeterminate nodules. Radial endobronchial ultrasound (rEBUS) bronchoscopy is often used due to a low rate of complications but its sensitivity is limited for small nodules.

The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity.

The primary outcome of this pilot, diagnostic validation, monocentric study is the sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule.

Secondary outcomes include the comparison of supernatant to pathology and plasma cfDNA methylation analysis.

Specificity, negative predictive value (NPV), positive predictive value (PPV) of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be analyzed.

60 patients planned for a rEBUS bronchoscopy for one, two or three \< 20 mm nodule, without mediastinal or extra thoracic lesions (cT1N0M0) will be included.

The day of the rEBUS bronchoscopy, 2 7.5 mL blood samples are collected. rEBUS samples' supernatant, usually discarded, is saved.

Cell free DNA is extracted from these biological specimens at the Laboratory of Oncological Medical Biology (LBMO) in Toulouse University Cancer Institute and tested for methylation (targeted analysis on 9 genes).

The patients will be followed for one year to obtain a final diagnosis and correlate it with tissue, nodule supernatant and plasma methylation analyses.

Eligibility Criteria:
Inclusion Criteria:

* rEBUS bronchoscopy planned for one, two or three ≤ 20 mm nodule
* World Health Organization (WHO) Performance status 0-3
* Informed signed consent
* Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage).

Exclusion Criteria:

* Lung cancer diagnosed before the date of the procedure
* Lung cancer strongly suspected due to mediastinal or extra thoracic lesions
* Patient under State Medical Assistance
* Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice