cyrilzakka/clinical-trials huggingface dataset:
Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index

One of the long-term effects of neck dissection applied to patients with head and neck cancer is shoulder dysfunction, which directly affects the quality of life. Patients complain of different degrees of shoulder joint problems following neck dissection . Shoulder syndrome in these patients is characterized by a set of symptoms including shoulder pain, abduction limitation, and scapular winging.The aim of this study is to make the Turkish Neck validity, reliability and cultural adaptation of the "Neck Dissection Impairment Index".

In the literature, there are many questionnaires aimed at patients with head and neck cancer, developed both specifically and specifically for this patient group, evaluating the quality of life. Regarding the shoulder problems experienced by these patients, there is only one item in the literature called "The University of Michegan Head and Neck QOL (UMHNQOL) questionnaire" that evaluates shoulder pain. Apart from this, there is no other questionnaire in the literature that may adversely affect the quality of life to neck dissection and question both neck and shoulder problems together. The Neck Dissection Impairment Index evaluates the shoulder-related quality of life in a more comprehensive and more detailed manner according to the UMHNQOL questionnaire. The Neck Dissection Impairment Index evaluates the components of shoulder related quality of life in a wide range after neck dissection. Because the type of age, weight, radiotherapy and neck dissection are the most important variables affecting quality of life, patients in the high-risk group (e.g. young individuals, patients who have received radiotherapy and modified radical neck dissection) evaluated with the Neck Dissection Impairment Questionnaire can benefit from an earlier and more intensive rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily accepting to participate in the study
* Patients whose native language is Turkish
* Patients or healthy individuals who have completed a minimum 11-month recovery period after selective or modified neck dissection

Exclusion Criteria:

* Having a pathological condition in the neck or shoulder that is not related to the treatments associated with head and neck cancer
* Cancer recurrence at the time of the evaluations
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.

Eligibility Criteria:
* Patients 18-70 years old
* Patients with moderate to severe Crohn's disease
* Patients who have had Crohn's disease for at least 6 months
* Patients who have previously been treated for Crohn's disease
Endoscopic Sleeve Gastroplasty for Morbid Obesity

Obesity and its related metabolic disorders are increasingly a heavy health burden to many parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes mellitus (T2DM). It is also an essential component for normalizing the blood glucose and preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However, life-style modification, physical exercise and dietary adjustment are ineffective measures which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the other hand, large scale long-term follow-up studies have confirmed the role of bariatric surgery in providing durable weight loss and remarkable improvement on medical comorbidities. Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the most widely adopted procedure worldwide because of its simplicity and effectiveness in weight reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are potentially life-threatening complications. LSG is also costly because of the need for expensive laparoscopic staplers.

A new endoscopic bariatric therapy, namely endoscopic sleeve gastroplasty (ESG), has recently been proposed as a non-surgical procedure for the management of obesity with or without diabetes mellitus. Preliminary data based on single arm series or phase II studies have reported promising short and intermediate term weight control effect.

However, whether ESG is a feasible option comparable to LSG in the intermediate term remains an unanswered question. In addition, physical and functional outcomes after ESG were not well documented in most of the reported series.

Realizing there is a knowledge gap in applying ESG to patients with morbid obesity, we propose to study and compare the efficacy of weight control and functional outcomes of ESG against conventional LSG. Through this prospective randomized trial, the safety profiles, quality of life and changes in fasting and post-prandial gut hormone secretion after the two procedures will also be assessed and compared. The evidence thus generated shall lay a scientific foundation for ESG which may become an alternative choice for patients who have concerns about complication and irreversibility of most bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

1. A BMI \> 35 kg/m2
2. A BMI \> 30 kg/m2 with T2DM
3. A BMI\>3 30kg/m2 with 2 or more co-morbidities

Exclusion Criteria:

1. Significant anaesthetic risk (\> ASA III)
2. History of diabetic ketoacidosis or hyperosmolar coma
3. Uncontrolled T2 DM with HbA1c \> 12%
4. A BMI \> 45 kg/m2
5. Malignancy diagnosed within 5 years
6. Endoscopic findings of any pre-neoplastic/neoplastic lesions, portal hypertensive gastropathy or significant varices
7. Chronic renal failure requiring dialysis
8. Previous upper abdominal surgery (including bariatric surgery) affecting gastroduodenal configuration
9. Major psychiatric illness including major depression and substance abuse
10. Pregnancy or ongoing breast-feeding
11. Inmates
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.

Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic, familial or associated PAH, WHO group 1
* NYHA class II or III
* clinically stable with optimized PAH treatment for at least 3 months
* no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment
* age \> 18 years
* mean pulmonary artery pressure (mPAP) \> 25 mmHg
* 6 minute walk distance (6MWD) over 100m

Exclusion Criteria:

* Structural heart disease unrelated to PAH
* Recent (\<3 months) treatment with an intravenous positive inotropic agent
* current use of β-blockers
* history of reactive airways disease
* history of adverse reaction to β-blockers
* heart block on ECG or resting heart rate \< 60 bpm
* cardiac index \< 1.8 l/min/m2
* systemic hypotension (systolic pressure \< 90 mmHg)
* pulmonary capillary wedge pressure \> 15 mmHg
* inability to give informed consent
* contraindications to CT and/or PET scanning
* coagulopathy (INR\>1.5 or platelet count\<50000/mm3)
* severe renal insufficiency (creatinine clearance \<30 ml/min/m2)
* malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.
Prospective Study of an Investigational Daily Disposable Contact Lens

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal eyes who are not using any ocular medications.
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Willing and able to wear spherical contact lenses for at least 5 days per week.
* Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
* Best spectacle-corrected visual acuity greater than or equal to 20/25.
* Manifest cylinder less than or equal to 0.75D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any active anterior segment ocular disease that would contraindicate contact lens wear.
* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Eye injury within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any clinical trial.
* Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
* Other protocol-defined exclusion criteria may apply.
High School Football and Adult Health

The primary aim of the study is to determine the effect of playing high school football on self-rated health in late adulthood. This is an observational study that will use data from the Wisconsin Longitudinal Study, a longitudinal cohort of high school graduates from 1957, to compare graduates who played high school football with comparable graduates who did not play football on self-rated health, pain, functional ability, and weight at the age of 65 years.

Data will be used from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957 to determine the association between participation in high-school football and self-rated health, pain, and obesity in late adulthood. The WLS is an optimal observational dataset to answer these hypotheses. WLS captures early-life exposures that are important predictors of health and well-being in later life such parental socioeconomic status, occupation, and education level, family structure, and race. It also captures whether study participants participated in high school football and contains detailed measurements of their health in adulthood. WLS provides a robust and longitudinal dataset, overcoming the limitations of prior cross-sectional studies, to compare the health in later adulthood of those who played high school football to those who did not, after carefully controlling for a potential confounders

A matched observational study will be conducted, in which football players and controls will be divided into smaller subgroups which are relatively homogeneous along a range of baseline covariates. The outcomes will be compared within each matched set, after adjusting for residual imbalances in the distribution of these baseline covariates between the football players and controls.

Eligibility Criteria:
Inclusion Criteria:

• Male

Exclusion Criteria:

* No yearbook information available to determine football playing status
* Sports participation in yearbook was not recorded under senior photo or in an index
* Played a high contact sport other than football (e.g. hockey)
Improving Parental Soothing by Video

This study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. The investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month infants undergoing routine immunization. The investigators hypothesize the active video will result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase in the parental use of distraction, physical comfort, and rocking.

Our goal is to determine if a video instructing parents on the principles of soothing their infant following immunization will influence soothing behaviours exhibited by parents, and pain reactivity and regulation in infants. We plan to present parents of young infants (6 months) and older infants (18 months) with either a Treatment Video instructing them on the ABCD's (Assess Anxiety, Belly Breathe, Calm Close Cuddle, Distraction; Copyright R. Pillai Riddell) of pain management or a Placebo Video with neutral information. There is very minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our ongoing longitudinal study) were doing naturally i.e., without any intervention in their day-to-day lives. Additionally, in a separate study, that already received ethics approval, parents viewed these videos without any negative side effects.

Participants will be adult parents from one of two clinics in the Greater Toronto Area who bring their infant in for a routine immunization (12 or 18 months). In our cohort study (where we simply videotape dyads in the clinic).

Parents will be asked to complete a brief questionnaire (Parent Information Sheet) entailing basic demographic information and preimmunization ratings of their worry about their infant's pain from the immunization. The parents will also be asked to complete the 18-item Brief Symptom Inventory (BSI-18) and the Negative Affect subscale (IBQ-R Very short form), in addition to demographic information. The parents will subsquently be asked to view a brief video (Treatment or Placebo Video) discussing the ABCD's of pain management described above. During the infant's routine immunization procedure the parents and infant will be videotaped for approximately 10 minutes, and the parent will be asked a few brief questions post immunization including ratings of their infant's pain from the immunization procedure and the helpfulness of the video.

Eligibility Criteria:
Inclusion Criteria:

* Infants must be 6 or 18 months old receiving a routine immunization injection.
* Parents must be fluent in English.
* Only one child per family can be enrolled.

Exclusion Criteria:

* No suspected developmental delays or chronic illnesses.
* Time spent in a Neonatal Intensive Care Unit.
* Born more than 3 weeks premature.
Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC

Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age is between 18-75.
* Patients who have signed informed consent form.

Exclusion Criteria:

* Patients who have undergone colonic resection or polypectomy.
* Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
* Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
* Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
* Patients with failed cecal intubation.
* Patients with poor BPQ necessitated a second bowel preparation.
* Patients refusing to participate or to provide informed consent
Treatment of Plantar Fasciitis With Platelet Rich Plasma

The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. It is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis.

Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection.

These questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment.

Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.

Subjects will be between 18 and 89 years of age.

In total, subject participation will last approximately 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with complaints of plantar heel pain, worse with rising in morning and/or after periods of sitting or lying presenting for at least 4 weeks
* Examination reveals maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus
* Willingness to participate in an investigational technique
* Willingness to forgo any other concomitant conservative treatment modality; NSAIDS and orthotic devices during the study period

Exclusion Criteria:

* Previous surgery for heel pain
* Nerve related symptoms (radiculopathy, tarsal tunnel syndrome, tarsi sinus syndrome)
* Patient with complex regional pain syndrome
* Achilles tendon pathology
* RA, DM, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
* Patients that are pregnant or breastfeeding
* Patients with metastatic cancer
* Dysfunction of the knee, ankle, or foot
* Work related or compensable injury
* Previous treatment: corticosteroid injection in the last 6 months or NSAIDs treatment within the last 7 days
Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation

Craniosynostosis is a condition where infants are born with or subsequently develop an abnormally shaped skull. The skull develops from plates of bone separated from each other by growth lines (sutures). Craniosynostosis refers to early fusion of one or more of these sutures.

Whilst in many cases the abnormal head shape provides doctors with the underlying diagnosis, it is necessary to confirm this using imaging. A CT scan involves using multiple x-rays to build a picture of the part of the body being examined. X-rays are associated with potential long term harm, particularly in young children who have longer to incur those risks. MRI uses magnets and radiowaves to create images of the body, and therefore a radiation-free method of imaging.

The investigators have previously shown in a pilot group that a specific MRI technique ("Black Bone") can distinguish between normal and prematurely fused cranial sutures, and that the images can be reconstructed in 3D in the same way as CT.

The investigators now need to confirm the findings in a larger patient group, and develop automated methods of creating 3D images of the bone.

Children in whom there is clinical suspicion of craniosynostosis will be recruited for MRI examination. In children who are already undergoing MRI examination of the head (for any indication), the investigators will add on bone specific sequences.

There are no known long term risks associated with MRI, and no contrast medium is required. Anonymised MRI data will be used to further develop our 3D techniques.


Eligibility Criteria:
Inclusion Criteria:

* Children in whom craniosynostosis is clinically suspected

Exclusion Criteria:

* Children with contraindications to MRI examination
* Children who require sedation/anaesthesia solely for the purpose of research MRI
Extension Study of Biostate in Subjects With Von Willebrand Disease

The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.


Eligibility Criteria:
Inclusion Criteria:

* Have completed Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in Paediatric Subjects with Von Willebrand Disease) or Study CSLCT-BIO-08-54 (Assessment of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with Von Willebrand Disease).
* The subject and/or his/her legal guardian understand(s) the nature of the study and has/have given written informed consent to participate in the study and is/are willing to comply with the protocol.

Exclusion Criteria:

* Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCT-BIO-08-54.
* Mental condition rendering the subject (or the subject's legal guardian) unable to understand the nature, scope and possible consequences of the study.
* Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
* Are not willing and/or not able to comply with the study requirements.
* Employee at the study site, or spouse/partner or relative of the Investigator or Subinvestigators.
* Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
* Intention to become pregnant during the course of the study.
* Pregnancy, or nursing mother.