cyrilzakka/clinical-trials huggingface dataset:
Assessment of 2 Different Techniques for Suppression of Respiratory Motion in Lung Cancer Treatment With Proton Therapy Using Magnetic Resonance Imaging (MRI)

Since 1996 proton therapy has been applied very successfully at the Paul Scherrer Institute in Switzerland to irradiate deep-seated, stationary tumors. In order to treat tumors within an organ which moves due to breathing (e.g. lung) motion mitigation strategies need to be implemented to ensure the precise irradiation of the moving target. The aim of this study is to assess the feasibility and compare (via MRI imaging) 2 techniques which "freeze" the movement of the lung by breath hold. One method is suppression of respiratory movement via high-frequency, mechanical ventilation by means of a Jet Ventilator (HFPV). The other technique is deep Inspiration breath-hold (DIBH) with Hyperventilation and simultaneous Inspiration of 100% O2 including daily breath-hold exercise.


Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent by signature
* healthy, i.e. normal physical and mental status

Exclusion Criteria:

* contraindications to MRI (non-MRI-suitable electronical \& metal implants, claustrophobia)
* women who are pregnant or are breast feeding
* acute or chronic illness
* known or suspected non-compliance, drug or alcohol abuse
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* presence of any psychological or sociological condition potentially hampering compliance with the study protocol
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing

The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination

Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.

The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years, male or female
* Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
* Hemodialyzed patients with hemodialysed sessions performed three times a week
* Patient able to give informed consent and affiliated to the medical insurance

Exclusion Criteria:

* Pregnant woman
* Patient never vaccinated against HBV
* Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
* Active neoplasia or plasma cell dyscrasia
* VIH infection
* Known allergy to vaccine or to PMMA membrane
* Patient dialysed with PMMA membrane within three months before screening
* Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration
* Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.
* Patient under judicial protection
Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults

When the literature search is conducted, it is seen that there are many studies examining the effects of COVID-19 disease on individuals in various disease groups (MS, stroke, Parkinson, COPD, asthma, etc.) and age groups (adult, geriatric, etc.). However, it has been determined that there is no study examining the impacts of this disease on functional capacity, physical activity, pulmonary function, emotional state, sleep, and quality of life in healthy young adults. This study will reveal whether COVID-19 disease causes an effect on the mentioned parameters in young adults. The aim of recent study is to investigate functional capacity, respiration, pain, depression, sleep and quality of life in young adults post COVID-19. For this purpose, participants' upper extremity and lower extremity muscle strength, 6-minute walking distance, O2 saturation, posture evaluation, spirometric evaluation, pain threshold, pain intensity, dyspnea, and leg fatigue measurements will be recorded. In addition to these measurements, general fatigue, quality of life, depression, physical activity level, sleep quality parameters will be evaluated and the data obtained will be analyzed with appropriate statistical methods.

The goals of recent work,

* To determine whether COVID-19 disease causes a decrease in functional capacity and changes in respiratory parameters in young adults, as well as to determine whether there are effects such as pain, depression, decreased sleep and quality of life,
* To determine whether there are significant changes in the values of the relevant outcome measurements in all the mentioned parameters,
* As a result of these, to determine the effects of COVID-19 disease on these parameters in young adults with objective, measurable data and to guide researchers and clinicians who do/will conduct studies on the subject.


Eligibility Criteria:
Inclusion Criteria:

* volunteers who are aged between 18-45 years
* cases, who were infected with COVID-19 and had at least 12 weeks after diagnosis
* cases, who have no symptoms of COVID-19 such as fever, cough, ageusia, anosmia, diarrhea, arthralgia, myalgia, sore throat, headache, chest pain

Exclusion Criteria:

* those have any cardiac or pulmonary disease history
* those have diagnoses of any psychological disease (major depression, anxiety disorder, etc.)
* those have any neurological or orthopaedic disease which hinders participation in physical activity
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment (RIBS VI)

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR.

Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.

Eligibility Criteria:
In-stent restenosis with ischemia. Signed Informed Consent IRB approval

INCLUSION CRITERIA:

PATIENT

* Age \> 20 and \< 85 years of age
* Acceptance of late angiographic evaluation
* Angina or objective evidence of ischemia

LESION

* ISR (\>50% diameter stenosis on visual assessment)
* Previous stent location known

EXCLUSION CRITERIA:

PATIENT

* Inclusion in other clinical research protocol
* Allergy to antiplatelet agents
* Women in childbearing age
* Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
* Recent myocardial infarction
* Time from index stent implantation \< 1 month
* Anticipated difficulties for late angiographic evaluation

LESION

* Stent thrombosis or large thrombus within the stent
* Angiographic failure during initial stent implantation or persistence or large dissection.
* Severe tortuosity or calcification or major difficulties during previous stent implantation
* Vessel diameter \< 2.25 mm (visual assessment)
* Stenosis outside stent stent edge (edge ISR are eligible)
* Very diffuse ISR (\>30 mm in length)
Reiki as a Complementary Therapy: A Pilot Study

This research is being done to test whether a complementary intervention, Reiki therapy, can provide added benefits to the standard patient care. Reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax.

We are studying the effect of a 15-minute Reiki application compared to an intervention of nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and improving patient outcomes. In the future we would like to offer complementary interventions as an adjunct to our standard care for patients.

This pilot study is designed to test if a complementary therapy, Reiki, has an effect on physiological and subjective measures of stress. This is a 2-arm randomized pilot study of the use of Reiki therapy prior to a stressful event with a convenience sample of 40 participants who are newly diagnosed hematologic malignancy patients on the inpatient service who will experience bone marrow aspirate post induction chemotherapy. Reiki therapy is a non-invasive complementary therapy that can be used in addition to the standard of care. The intervention group will receive a 15-minute Reiki session and the control group will receive 15 minutes of nursing presence. Each study arm includes a brief item questionnaire to rank subjective measures of pain, anxiety, and energy; saliva biological markers related to stress-reduction; and measures of blood pressure, heart rate, and respirations. The intervention group will receive a 15-minute intervention performed on the inpatient unit prior to the bone marrow aspirate procedure. Data will be collected from patients both before and after the intervention and before and after the bone marrow aspirate. We will collect saliva samples from the control group and baseline data including subjective measures of pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. The study nurse will maintain presence in the control participant's room for 15-minutes after the initial measures.

Our research hypothesis is that there will be a change in the response to one or more parameters of physiological or subjective measures for those patients receiving a Reiki intervention when compared to those receiving standard of care plus the nurse presence in room.

The null hypothesis is there will be no difference in response between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older admitted to hospital
* Speak English
* Able to give consent will be included.

Exclusion Criteria:

* Patients who are under 18
* Non-English speaking
* Unable to consent
* Pregnant women
* Unwilling to join the study will be excluded
* Intensive Care Unit (ICU) patients and those patients scheduled to receive conscious sedation will be excluded.
* Each patient may join the pilot study only once
Multicenter Registry on Robotically Assisted PCI - TESLA

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Corindus Vascular, Siemens Healthineers, Germany) in real-world interventional cardiology practice.

R-PCI represents a novel approach to performing PCI with several studies showing high technical success and low complication rates. The CorPath GRX System is the second generation of the CorPath platform, dedicated to advancing robotic-assisted vascular procedures to mitigate the orthopaedic and radiation-related occupational hazards associated with the practice of interventional cardiology.

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Siemens Healthineers, Germany) in real-world interventional cardiology practice in Europe and Asia.

All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System and completed one-year follow-up are eligible for recruitment in this registry, if older than 18 years. This study includes patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

The Study Investigators expect to enroll at least 700 patients (up to 1000). International centers that performed R-PCI with the CorPath GRX System will be invited to participate in this multicenter study.

Baseline, procedural, and follow-up data will be collected for all cases.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years,
* Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI),
* Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.

Exclusion Criteria:

- Unwillingness to provide informed consent (only if applicable).
Bosutinib In Subjects With Renal Impairment

This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, aged 18 to 65.
* Adequate hepatic function.
* Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl \<30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 \< CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl \>80 mL/min/1.73m2).

Exclusion Criteria:

* Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period.
* Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
* Uncontrolled hypertension (for renally impaired subjects only).
13C-Spirulina Nitrogen Content GEBT Study

The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).

In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% Nitrogen content will be administered. Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling. The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-85 years old at time of signing consent form
* Ability to eat test meal and provide breath samples

Exclusion Criteria:

* History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
* Symptoms consistent with delayed gastric emptying
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Receipt of an investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of Gastric Emptying Breath Test meal
* History of neurologic or psychiatric disorder
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.


Eligibility Criteria:
Inclusion criteria:

* Knee pain for 4 months;
* Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
* Patients able to understand the study conditions and willing to participate for its entire duration;
* Patients who signed written informed consent.

Exclusion criteria:

* Severe knee osteoarthritis of grade 4;
* Diabetes mellitus;
* Rheumatoid arthritis;
* Ongoing malignancies;
* Certified allergic reactions towards the administered drugs ;
* Malalignment of mechanical axis of the lower limb (varus \> 10 °, valgus \> 10 °);
* Coagulopathies;
* Severe cardiovascular diseases;
* Ongoing infections;
* Immunodepression;
* Anticoagulants or anti-platelet agents;
* Haemoglobin \< 11 g/dl;
* Platelet count \< 150,000/mm\^3
* Drug addiction;
* Alcoholism;
* Psychiatric disease;
* Pregnancy or breastfeeding.
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences.

Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity.

Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery


Eligibility Criteria:
Inclusion criteria:

* Routine ultrasound scan and delivery at St.Olav's Hospital
* Ability to speak Norwegian
* Singleton pregnancy
* Gestational age 289 +/- 2 days
* Cephalic presentation

Exclusion criteria:

- prelabor rupture of membranes
Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)

The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS for no less than one year and no longer than ten years
* Disease in the secondary progressive (SP) phase
* At least one relapse the last 3 years
* Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months

Exclusion Criteria:

* Serious or acute heart disease
* Severe depression
* Serious or acute liver, kidney or bone marrow dysfunction
* Epilepsy not adequately treated
* Pregnancy or lactation
* Alcohol or drug abuse
Ex Onc SLED: a Study Utilizing a Weighted Sled for Horizontal Resistance Training

This protocol seeks to analyze patient adherence and outcomes after monitored exercise sessions utilizing primarily weighted sled pushes and pulls for linearly progressed resistance training of individuals who have been diagnosed with cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20-89 years
2. Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment. They should also consent to use adequate contraception during the course of the study.
3. Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI and must be able to stand.
4. Participants must complete an assessment by EOC staff and be determined safe to engage in the workout regimen by the study exercise personnel. Any individuals not deemed safe to participate in the basic EOC exercise program will be referred to physical therapy or elsewhere

Exclusion Criteria:

1. Severe arthritic, joint, cardiovascular, or musculoskeletal condition that would interfere with exercise program
2. Individuals deemed able to engage in more intense resistance training utilizing compound movements will not be eligible
3. Pregnant women
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Sedation
* Combined ICP-temperature-probe
* Indication to lower body temperature \> 1.5°C
* Age ≥ 18 years

Exclusion Criteria:

* Body weight \> 120 kg
* Severe renal insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* High-grade heart valve stenosis or insufficiency
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* Cardiac dysrhythmia with bradycardia (heart rate \< 45 /min, QTc \> 450 ms, sick sinus syndrome, AV-block II-III°).
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads