cyrilzakka/clinical-trials huggingface dataset:
PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients

Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.

A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.

PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life.

PEP devices have been wildly used to reduce breathing frequency and expiratory flow limitation, change breathing patterns, improve gas exchange, as well as result in less airway collapse and air-trapping in patients with COPD.

Increasing COPD disease severity promotes a negative impact on exercise tolerance and magnifies the level of disability. Physical activity programs appear to safely ameliorate these COPD consequences, conferring beneficial effects on dyspnea and health-related quality of life.

The combination of PEP during aerobic exercise helps to get the most benefits from the exercise for a longer time and little dyspnea and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* • All gender COPD patients

  * Age will be 55-65 years.
  * Moderate to severe COPD patients
  * emphysema on CT scan (HU ≥ - 900)
  * Their FEV1 will be less than 80% predicted
  * Class II obesity (BMI of 35 to \< 40)
  * Medically stable
  * greater than 10 pack-year smoking history

Exclusion Criteria:

* • Very severe COPD - Lung cancer

  * Lung resection - Lung fibrosis
  * Heart failure - Cognitive disorders that affect the device application
  * Musculoskeletal or neurological disorders that interfere with an exercise program
  * requiring invasive or non-invasive positive pressure ventilation
  * inability to speak in complete sentences due to breathlessness
  * suspected elevated intracranial pressure - hemodynamic instability
  * recent facial, oral, or skull surgery
  * active hemoptysis (more than two tablespoons of frank blood per day)
  * pneumothorax - failure to comply with the research protocol.
  * uncontrolled hypertension, or other concomitant respiratory diseases
  * participate in any research or pulmonary rehabilitation program during the period of this study.
  * imaging changes of lung disease such as occupancy, exudation, and interstitial changes on CT scan
Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy

Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or order receiving the first HBOT
* Alert consciousness

Exclusion Criteria:

* Pregnancy
* Having any acute disorder of the ears or upper respiratory tract
* Having evidence of neurologic dysfunction precluding them from making an informed decision
* Having a tracheostomy or endotracheal intubation
* Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.
PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Male, or female (not pregnant or intending to become pregnant during the study)
* Between the ages of 18-30.
* In good general health.
* No specific contraindications to the drug being administered

Exclusion Criteria:

* Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder
* Subjects who meet criteria for substance abuse or dependence within the last 6 months
* Subjects with an positive urine screen for illicit drugs
* having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit
* Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year
* subject is left-handed.
* The subject suffers from claustrophobia, or phobia for injections or blood.
* Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
The Association Between Intraoperative Hypotension and Perioperative Stroke

The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.

Optimized intraoperative management may play an important role in perioperative stroke prevention. Maintaining blood pressure near preoperative baseline values may help decrease the incidence of stroke, however the related evidence is limited.Therefore, this study is to investigate the association between intraoperative hemodynamic variable and the risk of perioperative stroke after non-cardiac and non-neurologic surgeries. The secondary aim of this study is to establish the potential risk factors of the perioperative stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019
2. Age\>18 or older

Exclusion Criteria:

1. Patients received local infiltration anesthesia
2. Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion
3. Major vascular operation
4. Neurologic surgery
5. Cariac surgery
6. Intraoperative blood pressure measurements or postoperative neuroimagings measurements are not available
7. History of severe neurological or psychiatric disease
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise

The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Trained cyclist/triathlete (VO2peak \> 55 ml/kg/min for males and \>48 ml/mg/min for females)
* Healthy as per medical history and investigator's/physician's judgement
* Having given written informed consent

Exclusion Criteria:

* Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)
* Smoking
* Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)
* Diagnosed musculoskeletal disorders
* Adhering to a carbohydrate restrictive diet
* Participation in another study at the same time
* Blood donation in the 2 months before the first experimental trial
* Plasma donation in the 2 weeks before the first experimental trial
* Males: VO2peak \<55 ml/min/kg body mass
* Females: VO2peak \<48 ml/min/kg body mass
* Females: pregnancy
Cangrelor Ticagrelor Transition Study

To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.


Eligibility Criteria:
Inclusion Criteria:

* greater than / equal to 18 and less than 75 years of age

  1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic q waves on at least 2 contiguous electrocardiogram (ECG) leads.

     OR
  2. Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.

     AND
  3. Treatment with aspirin (ASA) 81 mg daily.

     Exclusion Criteria:
Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications

This registry will assess clinical outcomes following the use of Cryopreserved Amniotic Membrane (CAM) for the treatment of orthopedic and various other conditions. This registry will collect outcomes data via a registry of up to 100 patients who have received treatment with CAM in the post-market setting. Patients will be enrolled from up to five healthcare centers.

The objective of this registry is to collect outcomes data via a registry on the uses of CAM in the post-market setting, including:

* Adverse events related to the treatment, or the product, will be collected for up to 12 weeks following the treatment.
* Improvements in appropriate effectiveness markers for CAM use in patients treated for various conditions.
* Improvements in overall quality of life resulting from CAM treatment in patients.

An additional objective is to determine standard of care follow-up for the target treatments, including effectiveness metrics used and typical follow-up schedule.

This registry is intended to collect clinical data from patients for analysis purposes only and will not be used to treat patients. The plan does not allow for any deviation from standard of care practice. Therefore, there is no added risk to patients from participating in the registry.

The sponsor will use an electronic data capture (EDC) system for capturing all the data from the sites. The system will be built and validated prior to initiation of the sites. Each participating physician or appropriately trained designee shall enter data into the EDC system, providing all applicable data and documentation to the sponsor. Data will be reviewed for missing data, data consistency, and reasonableness of responses. Discrepancies will be resolved through a formal query process within the EDC system, and may involve direct contact with hospital staff.

The conduct of the registry will be supervised through a process of centralized and on-site monitoring. The sponsor may remotely monitor the registry for data completeness and for adverse events. On-site monitoring will be implemented as necessary throughout the course of the registry. The physician/clinic will provide direct access to source data/documents for registry-related monitoring, audits and IRB review.

Eligibility Criteria:
Inclusion Criteria:

• A patient is suitable for inclusion in this registry if the patient has been treated with CAM for any indication as per the standard of care practice.

Exclusion Criteria:

• Patients are excluded from registry enrollment if they are under the age of 22 years.
Standard Follow-up Program Cervix Cancer (SFP CERVIX)

Standard evaluation and follow-up data regarding complications of curative radiation treatment for cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Every cervical cancer patient with curative intent for radiotherapy, treated at our department

Exclusion Criteria:

* Non-curative treatment
* Part of the treatment is given in another hospital
Anesthetics in Rhytidoplasty - A Comparison Study

This study is a prospective, double-blind, randomized comparison study of different anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring (PKA-BIS) rather than general anesthesia, without increasing intra-operative time, side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift surgery performed by the principal investigator will participate.

PKA-BIS arm receives the following medications:

clonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)

General Anesthesia arm receives the following medications:

Pre-operatively:

Pepcid 20mg Scopolamine 1.5mg transdermal patch Versed 2mg Zofran 8mg Reglan 10mg Glycopyrrolate - dose determined by anesthesiologist

During the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic also varied based on anesthesiologist's choice)

Eligibility Criteria:
Inclusion criteria:

* Female
* 18 years of age or older
* Undergoing elective rhytidoplasty

Exclusion criteria:

* Male
* Under 18 years old
* Pregnant or breastfeeding
* Medically unfit to undergo surgery
* Undergoing brow-lift in conjunction with rhytidoplasty (due to the inability to properly secure the BIS monitor as it would lie within the surgical field)
Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity

The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life after treatment whilst the recurrence rate in electively irradiated lymph nodes should not be compromised.

A summary of the study protocol can be found here: http://rdcu.be/qgMv


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible)
2. Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
3. Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment.
4. Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
5. No distant metastasis (M0) (TNM 7th edition 2009)
6. WHO performance status 0-2
7. ≥ 18 years of age
8. Written informed consent

Exclusion Criteria:

1. Concomitant chemotherapy or EGFR inhibitors for this tumour.
2. Primary tumour of the oral cavity or unknown primary tumour
3. Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery.
4. Current participation in any other oncologic interventional clinical study for this tumor.
5. Uncontrolled diabetes mellitus.
6. Known or suspected HIV infection.
7. History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas)..
8. Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.
Imaging and Biomarkers of Hypoxia in Solid Tumors

Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.

To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring the oxygen content of a tumor and to establish the measurement of secreted markers in blood as an accurate and reliable method for measuring the oxygen content of a tumor.

Eligibility Criteria:
INCLUSION CRITERIA

* Any solid tumor malignancies of any stage meeting all of the following criteria: Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging). Examples include but are not limited to: locally advanced squamous cell carcinoma of the head and neck to be treated by either initial surgery or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at the time of percutaneous needle delivery of implanted fiducial markers.
* Patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study. Patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem.
* Greater than or equal to eighteen years of age.
* Sufficiently healthy to tolerate all study procedures.
* Organ and marrow function sufficient to undergo planned therapy.
* Ability to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA

• Pregnant or nursing
Study of Immediate Start of Progestin Contraceptives in Medical Abortion

This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.


Eligibility Criteria:
Inclusion Criteria:

Women having medical abortion desiring progestin-based contraceptives (injectables or implants)
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria:
Inclusion Criteria:

* Age 19-65 years at screening
* Body mass index (BMI) ≥35 and ≤50
* T2DM diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \< 10.0% at time of enrollment.
* HbA1c must be stable over a 3-month period.
* Weight stable over 3-month period
* Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
* Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
* If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
* Able to understand and sign informed consent documents.

Exclusion Criteria:

* Known or suspected allergy to nickel or titanium or nitinol
* Type 1 diabetes or poorly controlled type 2 diabetes
* Use of injectable insulin
* Any documented conditions for which endoscopy would be contraindicated
* Contraindication to general anesthesia
* History of chronic gastrointestinal disease
* Congenial or acquired anomalies of the GI tract
* Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
* Uncontrolled hypertension
* Pre-existing severe comorbid cardio-respiratory disease
* History of chronic gastrointestinal disease
* Specific genetic or hormonal cause of obesity
* Recent tobacco/nicotine product cessation (within 3 months prior)
Bimodal Stimulation Compared to Unilateral Cochlear Implant

The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .

There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

Eligibility Criteria:
Inclusion Criteria:

1. The lack of middle-ear infection.
2. Normative intelligence.
3. The lack of auditory neuropathy disorder .
4. Residual hearing in the non-implanted ear.

Exclusion Criteria:

1. Middle ear infection..
2. Below average intelligence.
3. Auditory neuropathy disorder.