cyrilzakka/clinical-trials huggingface dataset:
Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise

The study will be conducted on healthy young adults. Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), including muscle oxygenation, will be compared in treadmill and bicycle exercises.

In recent studies, sensor systems that measure the oxygen level in muscle tissue at the microvascular level have been developed. These devices working with Near Infrared Spectroscopy (NIRS, 630-850 nm) method; It provides measurements of muscle oxygenation level at rest and during exercise. It is known that significant changes in vastus lateralis oxygenation levels measured by the NIRS method are associated with various factors such as exercise intensity, exercise profile and training. The aim of this study is to measure the oxygenation level of the vastus lateralis muscle during the exercises performed on the treadmill and bicycle ergometer, and thus to reveal the effect of using different ergometers on fatigue and sportive performance.

Muscle oxygen levels will be measured and evaluated before, during and after exertion. In addition, blood pressure (BP), oxygen saturation (SpO2), dyspnea and fatigue parameters will be recorded and evaluated. If undesirable symptoms are observed during our study, the exercise will be terminated. Within the scope of the project, the acute effect will be examined with the measurements made with the Moxy device on the vastus lateralis muscle during the treadmill and bicycle ergonometer.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* No known disease
* Be between the ages of 18-25

Exclusion Criteria:

* Having cardiopulmonary disease,
* Have had lower extremity muscle or joint injuries
* Having an orthopedic/neurological disorder
* Smoking and alcohol use,
* Have suffered a lower extremity muscle or joint injury,
* Having an orthopedic/neurological disorder,
* Uncontrollable asthma,
* PaO2\< 50 mmHg,
* PaCO2\> 70mmHg,
* Individuals with a resting systolic blood pressure of 200 mmHg
Tiotropium Handihaler vs. Tiotropium Respimat in COPD

The purpose of this study is to determine if tiotropium Respimat will result in better ventilation distribution of the lung in COPD participants quantified by hyperpolarized XeMRI. This study is designed to simulate the real-life clinical setting where patients receive one-time instruction on the inhaler use.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients of either gender, age \> 40.
2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
4. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC \< 0.70 in all GOLD stages (http://www.goldcopd.org/).
5. Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1

   Exclusion Criteria:
6. Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks)
7. 24/7 oxygen use
8. Previous history of pneumothorax
9. Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
10. For women of child bearing potential, positive pregnancy test.
11. Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
12. History of claustrophobia
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
3. Access vessel able to receive 18 French introducer sheath
4. Life expectancy \> 2 years
5. Appropriate candidate for endovascular repair
6. Ability to comply with protocol requirements including follow-up
7. 21 years of age or older, male or infertile female\*\*

Exclusion Criteria:

1. Mycotic or ruptured aneurysm
2. Participating in another investigational device or drug study within one year
3. Documented history of drug abuse within six months
4. Myocardial infarction or cerebral vascular accident within six weeks
5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
6. Iliac anatomy that would require occlusion of both internal iliac arteries
7. Planned occlusion or reimplantation of significant mesenteric or renal arteries
8. Planned concomitant surgical procedure or previous major surgery within 30 days
9. Previous prosthesis placement in the aorta or iliac arteries
10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.

Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over the age of 18
* New York Heart Association (NYHA) Class II-III CHF
* Left Ventricular Ejection Fraction (LVEF) of \< 35%

Exclusion Criteria:

* Acute coronary syndrome
* Acute decompensated CHF
* Hypotension
* Recent significant arrhythmia
* Recent stroke
* Significant renal or hepatic impairment
* Pregnancy or child-bearing potential
Gastric Layering Study

This comparative study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two food emulsions. Two types of dairy based foods will be used, one which will sediment in the stomach and one that will not. On each of two study days, a total of 9 post drink MRI scans will be taken to assess gastric layering and emptying. Cannulation will allow blood samples to be taken periodically for subsequent analysis for the presence of specific digestion related hormones. A total volume of 36 ml of blood will be removed and volunteers will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.


Eligibility Criteria:
Inclusion Criteria:

* Male (hormonal status of women would introduce more variation within small group)
* Age 20-50y
* BMI 19-30
* Apparently healthy
* Normally eat lunch
* Willing to eat the finely grated cheese meal
* Provide written informed consent

Exclusion Criteria:

* Individuals with an intolerance or allergy to any of the constituents of the test meal
* Smokers or smoked within the last year (smoking affects satiety/hunger)
* Diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease
* Have had surgery on the stomach or intestine or suffered from gastrointestinal disease, whether diagnosed or self reported
* Regular (more than once in 10 days) use of antacids, laxatives
* Any problems with swallowing
* Take prescription medication for digestive or gastrointestinal conditions.
* Volunteers taking part in another study (other than a questionnaire based study).
* Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
* Individuals with special dietary requirements (eg vegetarians)
* If attended a study during the previous four months where combined blood sampling from previous study and present study would exceed 470mL.
* If any of the clinical screening results are indicative of a health problem which would affect the volunteers well-being or which would affect the study data.
* Refusal to give permission to inform GP of participation in study
* Recent unexplained weight gain or loss
* History of back problems or any other condition which limit ability to repeatedly sit up and lie down
* Hiatus Hernia
* MRI scanning specific exclusion criteria

  * Cardiac pacemaker or artificial heart valve
  * Any surgery in the last 6 months
  * Aneurysm clips (metal clips from surgery)
  * Implant, pump or any medical device in the body (eg cochlear implant, neurostimulator, intra-venticular shunt)
  * Worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings
  * Have artificial eyes or limbs
  * Have been injured with shrapnel or bullets
  * Suffer from fits, blackouts or epilepsy
  * Claustrophobia sufferer
Fluid Resuscitation in Patients Suffering From Burns Injury

This clinical study compares two fluid resuscitation treatments in patients suffering from burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be administered as infusion solutions. It will be evaluated whether Volulyte® is effective and safe, and provides any benefit.

Severe burns injury presents a unique resuscitation problem due to simultaneous loss of electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and protein from the circulation into the interstitial compartment. In the post shock phase of burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a positive fluid balance of many litres. This pilot study will compare two burns fluid resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte solution, Volulyte 6%, versus supplementation with Human Serum Albumin, HSA 50g/L) on patient outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable).

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years of age
* 15%≥ Burn Total Body Surface Area Injury ≤60%
* Signed written informed consent from patient or legal representative

Exclusion Criteria:

* Patient age \>80 years
* Delay of patient randomisation \>8 hours post-burn
* Known pregnancy
* Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment)
* High voltage electrical conduction injury
* Known severe liver disease
* Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure
* Intracranial bleeding (known active or suspicion of intracranial bleeding)
Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.

The study population consisted of members of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry.

From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283).

From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)

Eligibility Criteria:
Inclusion Criteria:

* Member of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007
* 18 years of age or older
* Had at least 183 days of continuous enrollment in the database
* No doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry

Exclusion Criteria:

* Less than 18 years of age
* Less than 183 days of continuous enrollment in the database
* At least one doctor visit associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry
Postoperative Delirium in Patients Undergoing Radical Cystectomy

In this study, post-operative delirium will be measured in patients undergoing surgery for bladder resection, and associated microRNA biomarkers will be evaluated in patients considered delirious and non-delirious after surgery.

With voluntary participation, this study requires participants to complete a self-administered cognitive evaluation (SAGE) before surgery to assess baseline cognitive impairment and early dementia; vital signs will be documented prior to surgery. During surgery, participants will receive a standardized general anesthesia regimen as described in the protocol. Several parameters will be measured during surgery, including bispectral monitoring to measure processed EEG. After surgery, fitness for cognitive evaluation will be determined by the Richmond Agitation-Sedation Scale (RASS) scale, and then emergence delirium will be assessed using the CAM-ICU scale. Fitness for discharge from PACU will be determined by an Aldrete score of 9 or more. Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS-11). Postoperative nausea and vomiting (PONV) level will also be documented. Postoperative Delirium (POD) assessment will be achieved by administering the memorial delirium assessment scale (MDAS) twice a day starting on day 1 through day 3 postoperatively. Pain NRS-11 score and PONV levels will also be documented at each visit. For microRNA testing, blood probes will be collected in 5mL purple top tube at surgical preadmission and post-surgery days one, two and three. Risks associated with participating in this study include normal risk associated with having surgery and general anesthesia; no greater than minimal risk is associated with blood collection. For the participant, there are no immediate anticipated benefits for participating in this study. The importance of the knowledge that is expected to result includes lower post-operative complications as a result of post-operative delirium, faster recovery, and shorter hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age and older
* ASA II or III
* Capable of and willing to consent
* Participants literate in English language

Exclusion Criteria:

* ASA IV or V
* Patients with severe visual or auditory impairment
* Inability to read and/or write in English
* Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
* Dementia of Alzheimer's type
* Parkinson's disease
* Multiple Sclerosis (MS)
* Vascular dementia
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.

Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
* Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
* BMI between 18.5 and 38, inclusive.

Exclusion Criteria

* Has chronic active GI disease other than celiac disease
* Has diabetes (Type 1 or Type 2).
* Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
* Has hemoglobin value below 8.5 g/dL
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.

Eligibility Criteria:
Inclusion Criteria:

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

1. Capable of giving informed consent, as required per institution
2. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria:

Any patient who meets any of the following criteria will not be eligible to participate in the registry

1. Has a life expectancy of less than 1 year
2. Any reason the clinician deems patient is unfit for participation in the study
Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP

Limb amputation results in many types of pain, including localized pain at the stump and projected pain experienced by the patient in the location where the amputated limb used to be, known as phantom limb pain (PLP). The aim of this study is to determine the relative benefits of mirror therapy vs mental imagery in reduction of phantom limb pain. Randomized clinical trial study design will be followed.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female gender with ages from 12 to 75 years (17).
* Individuals with a unilateral above-knee amputation (AKA) at least 6 months prior to the study.
* Experiencing phantom limb pain at least 3 months (16).

Exclusion Criteria:

* History of neurological disorders affecting pain perception or motor function (e.g., stroke, spinal cord injury, brain injury).
* Uncontrolled diabetes or other medical conditions that could affect healing or participation in the study.
* Pregnancy or breastfeeding.
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.


Eligibility Criteria:
Inclusion Criteria:

* Previous enrollment in Immunex protocols
* No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
* Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
* No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
* Receipt of investigational drugs or biologics (other than TNFR:Fc \[p75\]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
* Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
* Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study.
* Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH

Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre.

Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

See report:

Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

Eligibility Criteria:
Inclusion Criteria:

Symptoms of PSH according to Baguley scoring table

Exclusion Criteria:

No symptoms of PSH