cyrilzakka/clinical-trials huggingface dataset:
Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'

A retrospective review of all incisional hernia repairs at North Shore Hospital (NSH), Auckland, NZ was performed between January 2004 and July 2019. Patients who had an open or laparoscopic incisional hernia repair with mesh were included in this study. Patients were retrospectively followed up from the date of their operation until the end of the study period.


Eligibility Criteria:
Inclusion Criteria:

* Primary surgical procedure was incisional hernia repair with mesh

Exclusion Criteria:

* Suture repair
* Other hernia repair (not incisional)
* Operation notes unavailable
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)

The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.

This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.

The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.

Eligibility Criteria:
Inclusion Criteria:

* eighteen years old minimum;
* be living in Porto Alegre or metropolitan region;
* breast cancer stage 0 - III OR
* localized prostate cancer;
* undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study;
* hormonal therapy / manipulation planned to be active throughout the study duration;
* not engaged in any exercise training for more than once a week for the past 6 months;
* in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).

Exclusion Criteria:

* metastatic phase / progression of the disease or active regional location prior to beginning of the study;
* inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues;
* another family member, who lives at the same residence, participating in the study;
* planning to move or major absence (more than two weeks) during the study;
* history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months;
* chronic pulmonary disease that requires oxygen or corticosteroid therapy;
* kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant;
* severe nausea, anorexia or any other condition which does not allow to perform physical exercise;
* medical contraindication to exercise training.
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age between 19 and 45 years old.
2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems and chronic disease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

1. Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
2. History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
4. Subjects with galactose intolerance.
5. SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
6. AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
7. Serum Creatinine \> ULN
8. Previous history or present of drug abuse.
9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
11. Subjects treated IP within 2 months prior to the first dosing.
12. Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
13. Alcohol \> 21 units/week or cannot stop drinking.
14. Cigarette \> 10 cigarettes/day.
15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
16. Not eligible to participate for the study at the discretion of investigator.
Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years
* BMI 30 or greater kg/m2
* Participants can give a consent to the procedure
* Participants have no contraindications to LSG (gastric ulceration)

Exclusion Criteria:

* Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
* Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
* Patients with hiatal hernia \> 3 cm
* Patients with previous esophageal or stomach surgery
Using the High Resolution Impedance Manometry to Evaluate Swallowing Function After Cervical Spine Surgery

Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

Dysphagia is a well-known complication following cervical spine surgery, including anterior or posterior approach. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

In this study, using the high resolution impedance manometry to determine (1) whether the occurrence of dysphagia in the postoperative 1 or 7 days and 1 month in the patients receiving anterior vs posterior approach of cervical spine surgery (2) which muscle in the pharyngeal region would be destroyed Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged \>= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, and 1 week by HRIM and questionnaire.

This study would expect (1) that the posterior cervical spine surgery would result in dysphagia greater than baseline, but less than that of anterior cervical procedures; (2) decreasing upper esophageal sphincter (UES) pressure may be the reason of postoperative dysphagia in the anterior cervical spine surgery, resulted from the intraoperative traction; (3) decreasing hypopharyngeal muscle pressure may be the reason of postoperative dysphagia in the posterior spine surgery, resulted from the prone and flexion positioning.

Eligibility Criteria:
Inclusion Criteria:1. Patients who fulfill the criteria of cervical spine surgery under general anesthesia 2. Aged from 20-80 years old -

Exclusion Criteria:

- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.

2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)

The investigators want to know the role of Peripheral hematopoietic stem cell infusion in avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with Drug Induced Liver Injury.

1. The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC.
2. Patients having a complete clinical history and physical examination, receive routine chemotherapy.
3. Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time.
4. Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is used to detect the protein or gene expression associated with liver function.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be histologically confirmed with metastatic breast cancer;
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months;

Exclusion Criteria:

* previous history of other malignancies;
* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness.
Hypoxia Pre-conditioning and Mountain Sport

Mountain sport activities as for example hiking or skiing may involve the risk of adverse health events especially in older people not accustomed to the specific mountain sport at altitude or people with pre-existing health issues. Increased activation of the sympathetic nervous system and abrupt changes in heart rate and blood pressure are thought to trigger these adverse effects. Preventive measures include regular physical activity (i.e. training) and adequate medical treatment. Hypoxia pre-adaptation (e.g., pre-adapt one night at moderate altitude) and pre-conditioning (e.g., intermittent hypoxia (IH) training), which was shown to lead to some favorable sympathetic nervous system, ventilatory and metabolic adaptations and additionally exerts anti-inflammatory action, could be hypothesized of being a further preventive measure. The aim of this research project is to investigate whether intermittent hypoxia pre-conditioning or sleeping one night at altitude (i.e., current recommendation before practicing mountain leisure sports in the elderly) is able to increase oxygen saturation during passive hypoxia exposure and during simulated hiking and skiing at altitude. Additionally, it is aimed to investigate whether such procedure reduces the physiological responses (i.e., heart rate, its variability and blood pressure (including baroreflex sensitivity) responses as well as metabolic, ventilatory, inflammatory and redox responses) during these activities.


Eligibility Criteria:
Inclusion Criteria:

* Participants will include normally physically active males and females (age 50-70 years; New York Heart Association (NYHA) class I and II) with or without prior myocardial infarction, living \<600 m.

Exclusion Criteria:

* Persons with CAD will be excluded if they will not be able to perform light to moderate exercise, or had recent myocardial infarction and/or revascularisation (\< 8 weeks prior to inclusion in the study), episode of unstable angina, de-compensated heart failure, life-threatening arrhythmia, ejection fraction \< 50%, known symptomatic aortic outflow obstruction, severe hypertension (\>180/100 mm Hg), pulmonary hypertension or any other severe systemic non-cardiac disease. Exclusion criteria will additionally include regular smoking of more than five cigarettes per day, regular drug intake, habitual residence \> 600 m and one or more overnight stay at \> 1000 m during the previous 4 weeks.
Use of Perforator Flaps for Leg and Foot Reconstruction

Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia.

Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps, conventional reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free tissue transfer. All these procedures have their limitations and associated morbidity at donor site

Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by a source artery and vein through branches for all tissue layers between the skin and the bone, and showed that between neighboring angiosomes there are choked and true anastomotic arteries.

Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator flaps.

The big popularity gained by the local perforator flaps was due to their main advantages: 1) Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap, 3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of completely or partially primarily closure, 6) Technically less demanding, because they are microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.

Eligibility Criteria:
Inclusion Criteria:

1. Traumatic soft tissue defects on foot and leg.
2. Simple defects i.e., soft tissue loss, with or without, tendon injury.
3. Patients from 6 years to 60 years old

Exclusion Criteria:

1. Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection).
2. Complex defects (soft tissue with bone injury).
3. Patients below 6 years or above 60 years old.
4. Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus....etc.
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion criteria:

* patients between 18 and 85 years
* due to undergo elective PCI
* informed consent obtained

Exclusion criteria:

* PCI lesion specific conditions
* class III or IV congestive heart failure
* severe hypertension
* increased bleeding risk
* thrombolytic therapy within 24 hours preceding randomization
Stability of Motor Output in Aging Adults

The goal of this project is to examine the area of the brain that controls muscle movement for a group of muscles important for swallowing, and to see how that area changes over 2 weeks of time.

A large number of our nation's veterans develop dysphagia due to the myriad of potential etiological sources of swallowing disorders, including stroke and head and neck cancer. The Veteran's Health Administration has recently identified dysphagia as a major clinical focus for the VA system (Sullivan \& Dennis, 2006). In order to accurately assess adaptations in motor cortex, it is first necessary to have a reliable tool for measuring organizational representation in the motor cortex. Transcranial magnetic stimulation (TMS) is a desirable choice for such measurement because of the ability to identify causative relationships between an area of motor cortex stimulated and muscle response. Therefore, the specific research objectives of this proposal are:

1. To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age
2. To determine the neural representation of submental musculature in the motor cortex of healthy older adults between 60 and 80 years of age.

Twenty healthy adults, 10 men and 10 women, between the ages of 60 and 80 years will serve as research participants. TMS will be used to establish motor maps of the submental muscles. Subjects will undergo two testing sessions, on day 1 and day 14. The results from each session will be compared to assess excitability and representation within the motor cortex, and to assess stability and reliability of measurement.

Eligibility Criteria:
Inclusion Criteria:

* Between 60 and 80 years of age

Exclusion Criteria:

* History of dysphagia
* History of neurologic disease
* History of head or neck cancer
* History of stroke
* Untreated hypertension
* History of a heart condition or heart disease
* Currently pregnant
* Contraindication to TMS including:

  * Metallic hardware on the scalp in the area where TMS will be applied
  * Cardiac pacemaker
  * Implanted medication pumps or an intracardiac line
  * Prior diagnosis of seizure or epilepsy in the subject (childhood history of benign febrile seizure will not be a contraindication)
  * Poorly controlled migraine headaches
  * Previous brain neurosurgery
  * Medications that can lower seizure threshold (Appendix B)
  * Unstable medical conditions
  * Lowest motor thresholds above 80% on TMS
In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease.

Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: the Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used. Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.

The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease comparing chlorhexidine and ozone gels.

Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design:

* Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4)
* Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3).

Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications.

The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
* No systemic disease;
* Compliant patients.

Exclusion Criteria:

* Absence of dental implants;
* Neurological and psychiatric diseases;
* Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
* Pregnant and/or breastfeeding women;
* Patients undergoing anticancer therapy.
* Patients with poor compliance.
Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude

This study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.

The participants will be randomly allocated to either SJOV or nasal cannula oxygen supply in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the nasal cannula oxygen supply group, oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older;
2. underwent routine gastrointestinal endoscopy under procedural sedation;
3. consented to participate in this trial. -

Exclusion Criteria:

1. infection of the upper airway;
2. anatomical abnormalities of the face, nose, and upper airway;
3. coagulopathies;
4. anticipated or known difficult airway;
5. known allergy against propofol, soybeans, and egg;
6. absence from the high-altitude environment during the past 3 months. -
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
* No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist

Exclusion Criteria:

* Subjects who have been permanently discontinued from investigational product in previous qualifying study.
* Any new conditions or worsening of any pre-existing conditions as defined in the protocol.