cyrilzakka/clinical-trials huggingface dataset:
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

The purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.

Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients. Sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. Lack of exercise is associated with OSAS severity, independent of body mass. Participation and motivation to exercise is low in OSAS patients, with less that one third of the patients reporting regular exercise routines. We aim to investigate if aerobic interval training improves OSAS in obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/M2
* Apne - hypopnea index (AHI) \> 10
* No significant comorbidities
* Abel to exercise

Exclusion Criteria:

* Inability to exercise due to musculoskeletal conditions
* Known ischemic cardiovascular disease
* Drug abuse
* Mental illnesses
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing cardiac surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coiling embolization procedure due to cardiac surgery
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing cardiac surgery.
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation

This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.


Eligibility Criteria:
Inclusion Criteria:

* Documented paroxysmal, persistent or chronic non-valvular AF
* Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2
* Patients eligible or non-eligible for lifelong, oral anticoagulation therapy
* Life expectancy of at least 1 year
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria:

* Suspected or known intracardiac thrombus
* NYHA Class IV CHF
* Patients who has unstable and intractable angina pectoris
* ASD and/or atrial septal repair or closure device
* Recent myocardial infarction within 3 months
* Severe valvular heart disease, or implanted mechanical valve prosthesis
* Large PFO with significant atrial septal aneurysm
* Planned ablation procedure within 30 days of Occlutech LAA occluder® implant
* Resting heart rate \> 110 bpm
* Allergy to Nitinol, which is a result of nickel and/or titanium allergies
* Stroke/TIA within the last 30 days
* Thrombocytopenia, thrombocytosis, leukopenia, or anemia
* Symptomatic carotid artery disease
* LVEF \< 30%
* Mitral valve stenosis
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis
* Age \>18 years
* Sinus action in EKG
* Patient capable for informed consent
* Written and signed informed consent

Exclusion Criteria:

* Clinical overt signs of infections of any kind
* Active malign disease
* CRP levels above 50 mg/L
* Cardiac Pace Maker
* Atrial Fibrillation
* Refusal of informed consent
* Cardiac Transplantation
* Immunosuppressive medication
Bioimpedance and Arterial Distension

The overall objectives were to investigate if characteristic dimensions for tissue and vessels determined from measured bioimpedance spectra would provide the same values as dimensions determined from MR images of the upper arm and verify that temporal variations of impedances could be converted to blood pressure.

It is emphasized that measurements of pulse wave velocity was not a part of this trial, which implies that only uncalibrated blood pressures could be measured. The specific objectives were:

1. To determine conductivities and permittivities in the spectral region from 1 KHz to 1 MHz for persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. Both sexes should be represented.
2. To verify that temporal variations synchronous with the heartbeat could be measured on all three groups.

Hypotheses:

A. That experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments.

B. That the variations of the electrical parameters would exhibit little variation from person to person.

C. Those simple experimental relations can be established for the electrical parameters by including a simple vascularization model.

D. That it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat.

E. That the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years
* Mental ability to understand information to test subjects

Exclusion Criteria:

* Serious illness
* Allergic reactions to ECG or EMG electrodes
* Mentally unstable or unable to perceive instructions
* Metal implants
* Claustrophobia
* Disqualified for MR scanning
* Pregnant
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer

Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.

Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Primary left-sided breast cancer post surgery
* Planning for adjuvant breast/chest wall +-RNI

Exclusion Criteria:

* History of cardiovascular disease
* Previous chest radiation
* Bilateral breast cancers
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acute promyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negative myeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasms overlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blastic plasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification
* Life expectancy of ≥ 3 months
* Stable renal function without dialysis for at least 2 months prior to investigational product administration
* Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria

Exclusion Criteria:

* Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration
* Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to \< Grade 2
* Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
* History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity

Other protocol-defined inclusion/exclusion criteria apply
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.

OBJECTIVES:

* Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
* Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
* Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.

OUTLINE: This is a multicenter study.

Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)

  * Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy
  * Patients upstaged by imaging to N2 are eligible
* Measurable or evaluable disease

  * Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan
* Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies
* No distant metastases

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No active untreated infection
* No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin
* No concurrent major medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* More than 3 months since prior chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior head or neck radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No other concurrent treatment for head and neck cancer
* No prophylactic amifostine or pilocarpine
ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI)

This is an open-label, prospective single arm Phase II trial that investigates the role of ablative stereotactic body radiation therapy (SBRT) in oncogene driven metastatic non-small cell lung cancer (mNSCLC) patients with oligoprogressive disease (OPD) on targeted therapy (TKI) followed by circulating tumor DNA (ctDNA) analysis for tailoring targeted therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older.
2. Able to do most daily activities (ECOG 0-2).
3. Able and willing to sign an informed consent form to join the study.
4. Metastatic non-small cell lung cancer (NSCLC) with either an EGFR mutation or ALK rearrangement confirmed by imaging and biopsy.
5. Eligible for second-line therapy or targeted treatment (TKI) if in Group B.
6. Willing to give a blood sample for ctDNA analysis.
7. No limit to how many metastatic sites, but up to 5 progressive lesions that do not require immediate treatment.
8. Prior radiation therapy near progressive lesions is allowed if applicable.
9. Cancer lesions must be treatable with specific radiotherapy methods (like SBRT or ablative therapy).
10. Oligoprogressive disease is evaluated independently for each lesion using specific criteria.
11. Stable brain metastases allowed if asymptomatic and do not require corticosteroids.
12. Prior treatment with radiation for oligoprogressive lesions is allowed as long as they remain asymptomatic and re-treatment is possible.
13. Prior non-stereotactic radiation for palliative purposes is allowed, and if the lesion later progresses but is still asymptomatic and does not require immediate therapy, it can count towards the 5 oligoprogressive lesions.
14. Able and willing to complete quality of life and health utility questionnaires in English, French, or Spanish.
15. Accessible for treatment and follow-up.

Exclusion Criteria:

1. More than 5 extracranial sites of progressive disease.
2. Pregnant.
3. Leptomeningeal disease.
4. Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma.
5. Prior radiation therapy near the progressive lesion that would prevent treatment with SBRT due to exceeding limits of healthy tissue tolerance.
6. Any psychological, social, or geographic issues that could make it difficult to comply with the study.
7. Any other condition that the investigator believes makes participation in the study inappropriate.
Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy

Clinical trial to investigate the relationship between the expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67 in bladder cancer and pathological complete response after neoadjuvant chemotherapy.

This is a retrospective study included bladder cancer patients treated with neoadjuvant chemotherapy. We analyzed the changes in the expression of GATA-3, CK20, P53 and Ki67 before and after NAC. Evaluating the sensitivity factor for predicting pathological complete response.

Eligibility Criteria:
Inclusion Criteria:

1. Any male or female patient aged 18 or older.
2. Histologically confirmed bladder cancer, cystectomy was performed after NAC.
3. Complete clinical data.

Exclusion Criteria:

1. Patients with severe organic disease who can not tolerate chemotherapy or surgery
2. Patients received previous treatment (chemotherapy, radiation, or molecular targeted therapy).
3. Patients with distant metastasis or other cancer history.
Ultrasound-Guided Peripheral Intravenous Access by Critical Nurses.

Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.


Eligibility Criteria:
Inclusion Criteria:

* patient admitted in ICU
* patient not able to express his opposition
* central venous access that need to be removed
* need for a peripheral venous access
* no clinical instability
* no visible superficial vein due to: BMI\> 30, fluid overload, previous history of IV drug abuse, previous history of chemotherapy ,

Exclusion Criteria:

* patient \< 18 yo
* pregnancy
* patient under protective supervision
* need for a central venous access
Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery

The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.

The best way for dialysis in chronic renal failure (CRF) patients with consideration of feasibility, rate of infection, and patency is hemodialysis by using native access by using arteriovenous fistula (AVF).

Altered calcium and phosphor metabolism in CRF patients would also increase vascular reactivity. Stellate ganglion blockade (SGB) has been used for several years for both diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive SGB has been used in prevention of radial artery spasm in coronary artery patients.

SGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or ameliorates the reactivity of the muscular layer of the RA in response to both surgical manipulation during harvesting the artery and to the potent vasoconstrictor mediators released during surgery

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 75 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status III.
* Chronic renal failure (CRF) patients.
* Undergoing major lower limb orthopedic surgery.

Exclusion Criteria:

* Psychiatric disorders.
* History of substance abuse.
* Ipsilateral brachial and radial artery stenosis.
* Allergy to local anesthetics.
* Cardiovascular and respiratory disorders.
* Coagulopathy.
* Use of vasoactive medications.
* Obesity (body mass index \>30 kg/m2).
* Smoking.
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

This is a one month, phase 2, multi-center, randomized, investigator- and participant-blinded, placebo controlled study to assess the safety, efficacy and tolerability of remibrutinib (LOU064) in 3 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy. Participants will be randomized to remibrutinib low, medium or high dose for one-month treatment period (up to 5 weeks). Participants will have oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.

Eligibility Criteria:
Inclusion Criteria:

* Medical History of allergy to peanuts
* Positive peanut IgE \>= 0.35 kUA/L
* Positive Skin Prick test for peanut allergen during screening for study
* Positive Oral Food Challenge to peanut during screening for study
* Willingness to comply with study schedule and procedures and avoid other allergens during study period

Exclusion Criteria:

* History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
* Uncontrolled asthma
* Bleeding risk or coagulation disorder(s)
* Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
* History of splenectomy
* Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc.

Other protocol-defined inclusion/exclusion criteria may apply.