cyrilzakka/clinical-trials huggingface dataset:
Knee Osteoarthritis Risk in Retired Professional Footballers

The OA and Football Study is an epidemiological study designed to establish the prevalence of knee osteoarthritis in retired professional footballers. The study will also identify the key risk factors associated with knee osteoarthritis. The study is comprised of three phases: Phase I involves the dissemination of a questionnaire (demographic details, players history, injury and surgery and other known risk factors of OA), Phase II is a radiographic study that involves x-rays in a sample of footballers both with and without knee pain and Phase III is a case control study which will compared retired professional footballers with age-matched controls recruited from the general population in the East Midlands region.

Number of Participants:

Phase I: 1000 Phase II: 855 Phase III: 500

Primary outcome: The questionnaire will contain player specific information and will include validated outcome measures such as the health status questionnaire as well as self-reported pain, recall of injury and surgery history. The results of the questionnaire will be exported firstly to Excel and subsequently, into MS Access as part of a managed database.

Eligibility Criteria:
Phase I

Inclusion Criteria:

• All current or retired professional male footballers (Registered with the Professional Footballer Association (age range 40 -80)

Phase II

Inclusion Criteria:

* Professional footballers both with and without a history of knee pain knee OA or knee surgical history
* No contraindications of the affected joint such as gout or rheumatoid arthritis
* Willingness to participate in a clinical assessment of the knee and provision of blood samples.

Phase III

Inclusion Criteria for controls:

* Over the age of 40 (age range 40 - 80)
* Both with and without a history of knee pain over at least the last 1 year
* No history of significant trauma, injury or surgery to the lower limb
* American College of Rheumatology (ACR) classification of OA based on physical examination and clinical presentation: Pain in the knee and three of the following; over the age of 50, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement and no palpable warmth of synovium.

Phase I

Exclusion Criteria:

* Not a registered professional footballer (current or past)
* Inaccurate information (discrepancy with questionnaire information compared to other football records. This will be verified by the co-investigator, Dr Fernandes and Mr Sanjay Parekh)
* Incomplete questionnaire or duplicate questionnaire.

Phase II

Exclusion Criteria:

* Not a registered professional footballer
* No written informed consent to participate

Phase III

Exclusion Criteria:

* Aged 39 and under
* Comorbidities such as rheumatoid arthritis, gout, osteoporosis
* History of injury, trauma or surgery to the lower limb.
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis

The purpose of this study is to determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test.

Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture. However, it has been observed that rapid testing may not be accurate in children with a recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of rapid strep testing in children who are presenting with symptoms of strep throat, who also have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics, and antibiotic resistance.

The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat, fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the study.

A letter of consent will be provided to the parents and guardians of the involved child, stating that the study will be voluntary and confidential, and that all results will be kept in a safe environment.

Investigators will be testing the difference between two proportions, the false positive rate in previously treated compared to those not treated.

Eligibility Criteria:
Inclusion Criteria:

* 2-20 years old
* Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis.

Exclusion Criteria:

* Potential subjects who have been treated with less than 10 days of antibiotic therapy
* Patients who report non-compliance with previous antibiotic therapy
* Patients who have already been included in the study and children with evidence of GAS carrier status
Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the entire treatment period of the 28-week core study
* Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension study

Exclusion Criteria:

* Inability or unwillingness to undergo repeated subcutaneous injections
* Inability to comply with study or follow-up procedures
* Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
* Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS
* They are using simultaneously double barrier or two acceptable methods of contraception
* They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing
* They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing
* Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
* Partners have been sterilized by vasectomy or other reliable means

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Senobi Versus Buteyko Technique on Functional Performance of Chronic Obstructive Pulmonary Disease Patient.

Effect of Senobi breathing exercise versus Buteyko breathing technique on functional performance among chronic obstructive pulmonary patient.

chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus production and wheezing. Its typically caused by long term exposure to irritating gasses or particulate matter, most often from cigarette smoker.

Emphysema and chronic bronchitis are two most common condition that contribute to chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease is progressive disease that gets over a time. Clinical trials will be Conducted in Gulab Devi chest hospital in Lahore. Through the convenient sampling Technique. Which will be allocated through the random sampling two groups are involved group A and group B. In group A check the effect of Senobi techniques (stretch the body) and in group B check the effect of Buteyko technique. (Inhale the through the nose while mouth is closed) by using 6 mint walk test, Borg scale and quality of life questionnaire. Apply the technique to check the effectiveness of dyspnea and quality of life of patient The Buteyko technique offers a complementary method of reliving respiratory symptoms based on the voluntary control of breathing as well as considering the effect of environmental and dietary trigger. Data will be collected by the questionnaire and analyzed by using statistical package for the social science SPSS software version 21. The Buteyko method made its way to Australia to Europe and the unite states in 1990, it become best for the asthma and chronic obstructive pulmonary disease patient. The Senobi stretch exercise of the respiratory muscle improve the chest expansion and also improve the chest wall mobility in chronic obstructive pulmonary disease patient. Senobi breathing exercise was found to be effective for depression and it regulate the sympathetic nerve activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 -80
* COPD patient in stage 2 (GOLD criteria)
* Dyspnea (FEV1\< 70 %)(26)
* Maximum expiratory pressure: 50%
* Smoker

Exclusion Criteria:

* Patient with Tumor
* Patient with Cardiac Arrhythmias Patient
* Patient with cancer
* insulin dependent diabetes
* patient with thyroid disease
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

The therapy of pulmonary arterial hypertension (PAH) has been revolutionized with the development and subsequent instruction of oral endothelin receptor antagonists (ERA). The first approved ERA, bosentan (Tracleer, Actelion, Inc.) is an effective drug widely used throughout the world in the therapy of PAH. Newer ERA's, with purported advantages over the first approved drug have since been tested and subsequently been approved for the therapy of PAH in the USA and other countries including ambrisentan (Letairis, Gilead Sciences, Inc.). However, there is little data available on the efficacy, safety and tolerability of the elective change from oral bosentan to oral ambrisentan in PAH.

Eligibility Criteria:
Inclusion Criteria:

1. Patients followed routinely in the pulmonary vascular disease clinic at the University of Alabama in Birmingham, greater than or equal to 19 years of age.
2. World Health Organization (WHO) PAH Type I
3. WHO class I-IV symptoms (no functional class exclusion).
4. On bosentan, twice a day, with a maximum daily dose of 250mg, on a stable dose for 3 months with no clinical indication to discontinue the drug (i.e., increased liver function studies or other intolerance). Patients may be on other drug therapies for PAH, and also may be on oxygen therapy (intermittent or continuous).

Exclusion Criteria:

1. Known intolerance or allergy to ambrisentan.
2. Prior therapy with ambrisentan.
3. Current therapy with two phosphodiesterase-5 inhibitors.
4. Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and prostanoids) within 4 weeks of baseline study visit.
5. Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit.
6. Active participation in another clinical study involving the medical therapy of PAH.
7. Uncontrolled systemic hypertension or angina pectoris
8. Serum creatinine greater than 2.5 at or within 4 weeks of baseline.
9. Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit.
10. In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject.
11. In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry.
12. In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry.
13. A woman of childbearing potential who is not using an acceptable form of contraception.
14. Pregnancy.
15. In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.
Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure

The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.


Eligibility Criteria:
Inclusion Criteria: In order to be included in the study, participants must:

1. be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \> 1 child between 3-11 years, we will include the youngest)
2. smoke at least 10 cigarettes per day for the past year
3. indicate that they smoke around their child or in the car or home at least one time per week\]
4. have no intention of quitting smoking in the next 12-weeks
5. aged 18-65 years
6. be fluent in English
7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension)
8. not currently pregnant, planning to become pregnant, or breastfeeding
9. do not use non-cigarette tobacco (cigars, chewing tobacco)
10. have no prior use of any potential reduced exposure product
11. have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence

Exclusion Criteria:

* Does not meet all of the requirements of inclusion criteria
Combined RF Surgery of the Tongue Base and Uvulopalatopharyngoplasty (UPPP) for Obstructive Sleep Apnea

Introduction: The aim of the study was to investigate the effectiveness of combined bipolar radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a single session for obstructive sleep apnea (OSA) and to determine whether this combination is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria: obstructive sleep apnea not treated by CPAP

Exclusion Criteria: a history of previous surgery for OSA and only one level of airway obstruction
Visual Outcomes After Implantation of a New Multifocal Intraocular Lens

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity will be evaluated. A patient-satisfaction and visual phenomena questionnaire will also be administered.

Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam protractor after full mydriasis. The mean of the absolute values of degrees the intraocular lens was off axis was determined.

Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. The background illumination of the translucent chart does not depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were performed under the same conditions.

Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients were interviewed 3 months postoperative. Patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Any race
* Either gender
* Diagnosis of cataracts both eyes
* Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
* Subjects must have \> 1.00 diopter of astigmatism

Exclusion Criteria:

* Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
* Retinal abnormalities
* Diabetes mellitus steroid or immunosuppressive treatment
* Connective tissue diseases
Perioperative Pharmacogenomic Testing

This is a single centre, prospective feasibility study and pilot randomised controlled trial of patients scheduled for elective intermediate or major non-cardiac surgery. The investigators plan to randomise up to 200 patients who meet the inclusion criteria to standard care or to personalised perioperative care based on pharmacogenomic testing for drugs commonly used in anaesthesia and postoperative pain management e.g., opioids - morphine, oxycodone and tramadol; anti-emetics - metoclopramide and ondansetron; and non-steroidal drugs - celecoxib and ibuprofen.

The investigators hypothesise that pharmacogenomic testing is feasible prior to elective surgery and through 'personalised prescribing' for precision tailored perioperative care the investigators will improve patient's postoperative quality of recovery, including pain management.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent
2. Age greater than 18 years
3. Elective surgery scheduled greater than 1 week from preoperative assessment and date of pharmacogenomic testing
4. Moderate-Major surgery expecting to last two or more hours with anticipated admission of at least 1 night including: breast, melanoma, colorectal (laparoscopic or open), prostate, or other major surgery (e.g. oesophagectomy, head and neck cancer, retroperitoneal sarcoma, etc.)

Exclusion Criteria:

1. Day case surgery
2. Expected surgery duration of \< 2 hours
3. Urgent surgery expected within 1 week of pre-operative assessment
4. Emergency surgery
A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children

With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.

Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.

Eligibility Criteria:
Inclusion Criteria:

* children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection

Exclusion Criteria:

* patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.
Coeliac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis

Pain is prevalent among patients with gastrointestinal cancers. Standard procedures such as coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases. Meanwhile, splanchnic nerve neurolysis (SNN) as an alternative to CPN is more effective for cancer pain relief.

Although previous studies investigating the role of CPN/SNN mainly focus on pancreatic cancer cases, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.

Pain is prevalent among patients with gastrointestinal cancers. There is abundant evidence that coeliac plexus neurolysis (CPN) is effective in reducing pain, opioid requirement and related side effects for pancreatic cancer cases while the evidence for other upper abdominal cancer pain is less robust but emerging. Meanwhile, there is an increasing interest in utilising splanchnic nerve neurolysis (SNN) as an alternative to CPN for cancer pain relief.

Although previous studies investigating the role of CPN/SNN involved heterogenous types of intra-abdominal malignancies, majority of cases were pancreatic cancer. Therefore, their efficacy on non-pancreatic abdominal cancer pain may not be accurately determined.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18
* Diagnosis of unresectable intra-abdominal cancer
* Visceral pain attributable to the cancer with NRS \>= 4
* Able to understand instructions, give consent, complete questionnaires

Exclusion Criteria:

* Primary pancreatic cancer or metastatic disease involving pancreas
* Gross celiac axis distortion identified on imaging
* Acute abdomen condition eg. Intraabdominal sepsis, tumor rupture
* Other non-cancer causes attributable to the pain
* Gross ascites
* Previous coeliac plexus or splanchnic nerve neurolysis
* Contraindications to neurolytic procedures eg. Bleeding tendency; local or systemic infections; allergic to local anesthetics, contrast or alcohol; intestinal obstruction; anatomical distortion along needle trajectory
* Patients believed to be inappropriate for study by investigators
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.


Eligibility Criteria:
Inclusion Criteria:

-patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.

Exclusion Criteria:

* active systemic infection
* current active cancer
* active cancer treatment
* prior bone marrow transplant
* prior solid organ transplant
A New More Efficient Cycloplegia Scheme

The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)


Eligibility Criteria:
Inclusion Criteria:

* Children between 1 and 10 years

Exclusion Criteria:

* Strabismus
* Ocular surgery
* Another ocular disease than ametropias (i.e uveitis, cataract)
* Cardiovascular or neurologic disease.
* Allergy to any of drugs used in the study