cyrilzakka/clinical-trials huggingface dataset:
Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM).

Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144 ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from echocardiograms and measures of left ventricular pressure obtained from patients in those studies will be analyzed in the current study to assess their influence on exercise capacity. No additional tests, treatments or other procedures are required.

Information from this study may help in the development of improved drug treatments for HCM.

NIH Protocols 01-H-0066, Double Blind Placebo Controlled Study of Pirfenidone A Novel Anti-Fibrotic Drug in Symptomatic patients with Hypertrophic Cardiomyopathy (HCM) Associated with left Ventricular Diastolic Dysfunction and 96-H-0144, Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) On Genetically-Induced Left Ventricular Diastolic Dysfunction were undertaken to assess the effect of therapeutic interventions on left ventricular (LV) diastolic function. The relationship between baseline measures of diastolic function as assessed by noninvasive modalities such as Doppler echocardiography and radionuclide angiography, and qualitative and objective measures of functional capacity in patients without LV outflow tract obstruction has not been reported. In this protocol we will look at measures of LV geometry, relaxation and novel indices of ventricular compliance as they may influence measures of exercise capacity. In all cases, we will use pre-existing baseline data obtained with informed consent as part of the above protocols.

Eligibility Criteria:
* Eligibility criteria not listed; Analysis of data from previous studies.
Nissen Versus Dor Hiatal Hernia Repair

Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation

Participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Type II-IV hiatal hernia, confirmed by radiology or endoscopy
* Scheduled for mini-invasive hiatal hernia repair
* Emergency mini-invasive surgery for hiatal hernia
* The informed consent is acquired

Exclusion Criteria:

* Recurrent hiatal hernia
* Need for esophageal lengthening procedure (Collis)
* Gangrene or need for any resection during (emergency) surgery
* Need for laparotomy or thoracotomy/thoracoscopy
* No written consent
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis

This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. This study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the MET to be run.

This study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an LDT. Following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.


Eligibility Criteria:
Inclusion Criteria:

1. Be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis
2. Provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics)
3. Be fit to undergo all procedures listed in protocol
4. Be able to provide written informed consent

Exclusion Criteria:

1. Has had a prior surgical diagnosis of endometriosis at time of blood collection
2. Is unable to communicate in written and spoken English
3. Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. This reason must be recorded on the CRF
Airway Ultrasound Assessment in the Prediction of Difficult Airway

To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.


Eligibility Criteria:
Inclusion Criteria:

* Patients risk ASA I-IV
* Non-urgent surgery under general anesthesia with orotracheal intubation
* Acceptance to participate and grant written consent

Exclusion Criteria:

* Urgent surgery
* Patients with a history of craniocervical pathology (trauma, tumor, malformations)
* Pregnancy
* Patient Refusal
Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial

To determine the impact of overcuffing (using a too-large cuff) and undercuffing (using a too-small cuff) on initial BP and average BP measurements when using an automated BP device, overall and stratified by appropriate cuff size

To determine if the impact over- or under-cuffing differs based on the following patient characteristics:

1. Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive.
2. Arm circumference (continuous)
3. Obesity status

The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have 2-3 sets of three automated BPs measured, each set with a different cuff size. To accomplish this, the investigators will utilize a 2-3 period cross-over design:

• Two or three different periods with 3 automated BP measurements, using a BP cuff that is:

* Appropriately sized based on mid-upper arm circumference ( standard)
* Too small (one size lower than appropriate)
* Too large (one size higher than appropriate)

Individuals in whom the smallest available cuff (small adult) and largest available cuff (extra-large cuff) is appropriate for their arm circumference will only be able to undergo two periods of BP measurements.

Eligibility Criteria:
Inclusion Criteria:

* 18-80

Exclusion Criteria:

* Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
* Being mentally impaired, pregnant.
* Arm circumference exceeding 50 cm.
Intervening on Women's Health for Rural Young Cancer Survivors

The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.


Eligibility Criteria:
Inclusion Criteria:

* Cancer (Stages 0-IV) diagnosis
* Primary language English or Spanish
* Receiving oncology care at rural oncology clinical participating site
* Living in Imperial County, California

Exclusion Criteria:

- Women who are pregnant at recruitment
Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath

The study does not involve testing of a drug (no treatment intervention). The study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).


Eligibility Criteria:
Inclusion Criteria:

- Male or female - ≥40 years of age - Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years - Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years - Completion of written informed consent prior to study participation - Subject must be able to read, comprehend, and record information in English.

Exclusion Criteria:

- Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. - Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc. - Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency. - Any medical or physical condition that would interfere with the adequate performance of spirometry. - Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit. - A spirometrically confirmed diagnosis of COPD. - Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse. - Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study. - Pregnant females. - Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.
Automating Breast Radiation Therapy (RT)

Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT) planning process. The investigators plan to examine data from another scan called Cone Beam Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used for treatment). Using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. By doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
* Patients with any stage of breast cancer.
* Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
* Able to provide a written informed consent.
* 18 years of age or older.

Exclusion Criteria:

* \< 18 years of age.
* Unable to provide informed consent.
* Males.
* Patients who received partial breast radiation and not the standard dose.
* Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions.
Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus

The purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. It will also understand the safety of this treatment regimen.

This study is a single-center, parallel-group, randomized self-controlled trial. The researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus.

Participants will:

One side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy Clinical examination at 2, 4, 8, and 12 weeks after treatment Note down the size of their erosion lesion area and periodontal clinical parameters


Eligibility Criteria:
Inclusion Criteria:

* Existence of erosive oral lichen planus that lasts for more than 2 months
* Erosive lesions are located in the buccal mucosa and gingival buccal sulcus of the bilateral mandibular posterior teeth area
* The erosive lesions are mild to moderate (single or multiple small area erosions; 3mm ≤ longest diameter ≤ 10mm; 9mm2 ≤ total area of erosions ≤ 100mm2), and the degree of erosion on both sides is similar (the difference in the size of erosion on both sides does not exceed ± 25%)
* The plaque index in the area of erosive lesions is ≥ 3; Dental calculus index ≥ 2; Gingival index ≥ 2;
* Accompanied by stage II-IV extensive periodontitis

Exclusion Criteria:

* Pregnant women, lactating women, or women planning to conceive during the trial period
* Patients with coagulation dysfunction or other uncontrolled systemic diseases who cannot undergo periodontal treatment
* Has undergone basic periodontal treatment within the past 6 months
* Individuals with a history of allergy to local anesthetic drugs such as articaine
* Individuals with contraindications to glucocorticoids
* Patients with lesion area erosion caused by trauma or chemical stimulation
* Patients with mental disorders who are difficult to cooperate with treatment
MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children

The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects.

A new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children


Eligibility Criteria:
Inclusion Criteria:

* Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation
* inhalation induction
* elective surgery
* ASA status 1 or 2
* consent of the child if he/she is able to express it
* consent of both parents and/or legal guardians
* socially insured

Exclusion Criteria:

* Child under 2 years old or \> 10 years
* body weight is over 40 kgs
* ASA status 3 or higher
* Emergency surgery or unscheduled surgery
* scheduled ENT or esogastric surgery
* Achalasia of the esophagus or history of GERD pathology
* History of esophageal surgery (NISSEN type)
* BMI indexed to age and sex showing childhood obesity
* Predictable mask ventilation difficulties
* History of Tracheostomy
* Child not insured by social security
Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis

To compare the result of mini monaka to perforated plug and 3 snip punctoplasty in management of punctal stenosis.

Punctal stenosis is a common disorder of the punctum. It is an important cause of epiphora and accounted for 8% of all patients presenting with epiphora and 3% of all lacrimal drainage disorders. Although numerous factors have been implicated as causative agents, the exact pathogenesis is still elusive. The widely believed hypothesis that histological studies have supported is a common mechanism involving inflammation leading to fibrosis and subsequent stenosis .A stenotic punctum can be easily diagnosed by slit-lamp examination, while probing and irrigation of the lacrimal pathway is usually required to exclude a more distal obstruction There are no uniformly acceptable guidelines for the management of punctal stenosis. Several modalities described include punctal dilatation, 1-snip punctoplasty, 2-snip punctoplasty, 3-snip punctoplasty, rectangular 3-snip punctoplasty, 4-snip punctoplasty, punctal punching with Kelly's or Rsess punch, punctoplasty with mitomycin C, balloon punctoplasty, balloon puncta-canaliculoplasty, and inserting perforated punctal plugs, self-retaining bicanaliculata stents, or Mini-Monaka . The mini-monaka is a silicone post canalicular stent designed to repair canalicular lacerations. It is designed to fit snugly into the punctum and ampulla without any suturing .A perforated punctal plug can be put into the opening of the tear canal to allow drainage of tears. These are very small silicone arrowhead shaped tubes It is important to note that there is increasing evidence about the benefits of minimally invasive modalities like Mini-Monaka. the non-surgical dilation can be performed as an office procedure .

Eligibility Criteria:
Inclusion Criteria:

* o Confirmed unilateral or bilateral cases of punctal stenosis based on slit-lamp examination.

Exclusion Criteria:

* o Epiphora due to distal obstruction

  * Active ocular infection or inflammation.
  * Anatomic abnormalities
  * Ocular cicatricial pemphigoid
The Impact of Infectious Disease on QT Segment

Sepsis related to the development of cardiac complications. However, the investigators understanding regarding this condition remains incomplete. Possible explanations raised include coronary perfusion decrease, activation of the coagulation system and release of inflammatory mediators, including endotoxins, cytokines and others.

In this study the investigators wanted to examine the impact of any infectious disease, (not necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious disease.


Eligibility Criteria:
Inclusion Criteria:

* Internal ward hospitalized patient, due to illness which its etiology is bacterial, fungal or viral

Exclusion Criteria:

* Can not technically perform reliably ECG (amputated legs, lack of cooperation, etc.)
* Subject with permanent pacemaker
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed the Treatment Period of N01358 or the evaluation period of N01258
* Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
* Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
* Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria:

* Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
* Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous BRV study
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the Investigator's opinion, warrants exclusion
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction

The optimal timing of surgery in patients with acute myocardial infarction (AMI) and the utilization of preoperative intra-aortic balloon pumps (IABP) in these patients are subjects of ongoing discussion and disagreement. This study aimed to investigate the effects of preoperative IABP on troponin levels, surgical timing, and intraoperative and postoperative outcomes for patients with AMI who undergo coronary artery bypass grafting (CABG).

Percutaneous coronary intervention (PCI) is the first treatment for myocardial ischemia; however, if left main coronary artery disease, multivessel disease, or complex architecture disable PCI, 10% of patients may need coronary artery bypass grafting (CABG). Abstinence from surgical reperfusion in patients with acute myocardial infarction (AMI) may be justified due to surgery's 50% mortality rate. An intra-aortic balloon pump (IABP) can help patients who have ongoing ischemia and high cardiac enzymes because it changes the way the heart uses oxygen by increasing coronary blood flow and lowering afterload. Some guidelines do not recommend the use of IABP in patients with AMI except for mechanical complications or shock. Nevertheless, it is commonly acknowledged that the specific criteria for employing IABP differ among clinics and are determined by clinical expertise. Patients with AMI who have impaired coronary perfusion and require surgical revascularization can benefit from preoperative intra-aortic balloon pump (IABP) support. This intervention leads to reorganization of coronary perfusion, resulting in a decrease in elevated troponin levels and quicker myocardial recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization

Exclusion Criteria:

* mechanical complications of Acute Myocardial Infarction (such as a ruptured chordal or ventricular septum)
* peripheral arterial disease
* renal failure
* history of cerebrovascular accident
* acute cardiogenic shock and cardiac arrest
* reoperation and combined operations