cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors

This study will involve collaborating with oncologists in the post-chemotherapy follow-up appointments. The participants who wish to consent to this study will then answer 3 short questionnaires (THI, HHIA and SF-36) about hearing loss, tinnitus and quality of life. The audiologist or the researcher, under the supervision of an audiologist, will then perform a simple, non-invasive hearing test on the participant. Should the participant have a hearing loss, they will be advise to seek help from their General Practitioner.

There has been a substantial increase in cancer survival rates in the the past decades, however many cancer survivors are now impacted by the multitude of toxicities associated with treatment. It is only when temporary toxicities subside that the long-term toxicities progress and become important. Chemotherapy, although highly effective, is known to cause ototoxicity, presenting as hearing loss and tinnitus. Hearing loss and tinnitus are associated with a higher risk of depression, dementia, social isolation and anxiety. There is little information and support offered to patients who suffer from ototoxicity, which can potentially lead to many being undiagnosed and untreated. Ototoxicity can be permanent and progressive, therefore it is essential that a deeper understanding and increased awareness of how hearing loss and tinnitus affects the quality of life (QoL) of cancer survivors can improve long-term symptoms Management and support offered.

This project aims to identify the prevalence and severity of long-term ototoxicity in cancer survivors following platinum-based treatment. Prevalence of ototoxicity can be unreliable and varies in the medical literature, with studies reporting rates between 24% and 79%. Information on prevalence will be achieved by recruiting patients from oncology clinics and performing a high frequency audiogram. The results from the audiogram will be compared to an normative dataset in addition to detecting self-reported hearing loss from the Hearing Handicap Inventory for Adults (HHIA) and the Hearing Handicap Inventory for Elderly (HHIE) questionnaires. Furthermore, the severity and prevalence of tinnitus will also be detected by using the Tinnitus Handicap Inventory (THI) questionnaire. A validated questionnaire assessing QoL (SF-36) after cancer will also be completed by the patients. The questionnaires will be statistically analysed and compared against a dataset from the general population in the hope to identify the concerns surrounding long-term ototoxicity in cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent

  * Age 18+ at time of cancer diagnosis
  * At least 1 cycle of any type of platinum-based chemotherapy
  * 0-5 years following first cycle of platinum-based chemotherapy
  * Comprehensive understanding of the English language

Exclusion Criteria:

* Previous radiotherapy to the head and neck area
* Pre-existing hearing deficits
An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.

The participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the investigator will inform the participant and make an appropriate referral. This is standard practice for laser in situ keratomileusis (LASIK) surgery, small incision lenticule extraction (SMILE) and photorefractive keratectomy (PRK) surgery.

If the participant is deemed appropriate for the study after a comprehensive examination including computerized videokeratography, then the participant can be enrolled. These exams are also standard practice for LASIK, SMILE and PRK surgery.

The Quality of Vision (QoV) Questionnaire will be administered following the pre-operative visit during which participants are enrolled and then at the three-month and twelve-month post- op visits before the participants are seen by the principle investigator. The questionnaire is the study intervention.

The participant will undergo bilateral simultaneous LASIK eye surgery, SMILE or PRK surgery. The participants will be seen pre-operatively, on the day of surgery, post op day one, one month, three months, and twelve-months as part of the study. Participants may also be seen more frequently if required from a medical standpoint. The participant will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week to four weeks after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK, SMILE and PRK surgery.

Eligibility Criteria:
Inclusion criteria.

* 21 years or older.
* A physician or medical student.
* Have the ability to give informed consent.
* Speak and read English fluently.
* Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
* May benefit from increased spectacle independence.
* Have been determined to be a good candidate for the LASIK, SMILE or PRK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
* Have a treatment target of bilateral emmetropia.
* Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator.
* Are not enrolled in any other research study.

Exclusion criteria.

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectatic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
Brief Virtual Mindfulness-based Group Intervention with Social Support for Perinatal Individuals

This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* Have a single gestation pregnancy
* Fluently speak English
* A history of significant substance use or currently in treatment for a substance use disorder.

Exclusion Criteria:

* Inability to provide consent
A Study of Objective Fitting for Focused Multipolar Stimulation

The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

This study will compare various objective and behavioural fitting methods for the programming of Focused Multipolar Stimulation. Fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. Focused Multipolar Stimulation (FMS) is an alternative to the standard of care Monopolar Stimulation (MP). FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over MP stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. Moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 dB HL pure-tone average loss)
2. Candidate for unilateral cochlear implantation according to locally approved criteria.
3. Aged 18 years or over.
4. Fluent speaker in the language used to assess speech perception performance.
5. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
3. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
4. Pregnant at the time of surgery.
5. Prisoners, or anyone in custody.
6. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
7. Previous or existing cochlear-implant recipient.
8. Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
9. Duration of severe to profound hearing loss \>20 years in the ear to be implanted.
10. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
11. Diagnosis of auditory neuropathy.
12. Deafness due to lesions of the acoustic nerve or central auditory pathway.
13. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
14. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.

Excision in the midline and primary suture is a long proven method of treating pilonidal sinus. However it's associated with high incidence of post operative infection and recurrence. On the other hand Karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. The purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. In addition the investigators aim to compare the quality of life at defined time points after surgery. Eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the Karydakis operation (expertise based design). The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.

Comparison: Midline excision andd primary suture compared with the Karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Surgery is considered the best available treatment.
* The patient understands trial information and is capable of making a decision for informed consent after having received information.
* The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.

Exclusion Criteria:

* Patient has had a pilonidal abscess during the last four weeks before the planned day of surgery
* Patient has had surgery (excision) for pilonidal sinus more than once before.
Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor (ICM) device.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older and is willing to be implanted with the Reveal ICM
* Currently on hemodialysis at least three times per week OR has an estimated glomerular filtration rate (eGFR) of \< 15 mL/min/1.73m\^2 and is expected to begin hemodialysis within 2 months.
* Subject is willing and able to comply with the protocol

Exclusion Criteria:

* Currently enrolled in an interventional study that may interfere with the Monitoring in Dialysis protocol
* Not suitable for Reveal ICM implantation
* Has an existing hemodialysis catheter that may interfere with the Reveal ICM implantation site
* Has a recent infection
* Is currently on hemodialysis with a hemoglobin \< 10 g/dL
* Has end-stage liver failure or has had thoracic surgery within the past 6 months
* Has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization device
* Is scheduled for renal transplantation or will likely be transplanted within 6 months
* Is currently on home hemodialysis
Virtual Reality Training Intervention on Cognitive Function and Quality of Life

The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities. Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The passive control group received usual care.

Objectives: The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities.

Method: Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The VRCTI comprised 12 different tasks distributed in 8 sessions with different difficulty levels. The passive control group received usual care. Older adults were randomly assigned to either VR or control groups. An experimental pre-post design was used. Accuracy, error, and repetition rates were measured throughout each session. Intervention effects were analyzed using a generalized estimating equation model.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 65 years
* Admitted as residents at the study-site institutions (long-term care facilities)
* Mini Mental Status Examination (MMSE) ≥ 13
* Able to communicate sufficiently

Exclusion Criteria:

* Open facial wounds
* Problems with a finger, hand, or wrist and/or major visual or auditory impairment, making it difficult to deliver training scheme
* Major neurological or psychiatric conditions that may affect cognition (e.g., stroke, dizziness, schizophrenia)
* Unstable medical conditions
* Were unable to comply with the intervention
Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Age \> 45 years
* Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

Exclusion Criteria:

* Skin lesions or dermatological diseases in the treatment area
* Directly or indirectly involved in the conduct and administration of this study
* Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
* Pregnancy or lactation
* Residents of psychiatric wards, prisons or other state institutions
* Malignancy within the past 2 years
* Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
* Epilepsy
* Schizophrenia
* Neuropathic pain and any other pain condition requiring chronic use of pain medication
* Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
* Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
* Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.


Eligibility Criteria:
Inclusion Criteria:

1. Resection of following organs (clean-contaminated open surgery)

   * Liver, Pancreas, Bile duct, Duodenum
   * Stomach
   * Colon, Small bowel
2. Aged 20 - 85 years old
3. Use Prophylactic antibiotics
4. Use Preoperative bowel preparation
5. Elective operation
6. ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease \& mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
7. adequate organ functions defined as indicated below:

   * WBC 3000 \~ 12 000/mm3
   * \> Hb 8.0 g/dl
   * \> Plt 100 000/mm3
   * \< Cr 1.2 mg/dl

Exclusion Criteria:

1. allergy to chlorhexidine or povidone
2. clean surgery or contaminated surgery
3. patients who cannot be followed up during 1 month
4. patients taking immunosuppressant drugs or chemotherapy agents
5. emergent surgery and reoperation
6. uncontrolled diabetes, BMI \> 30 kg/m2
7. vulnerable patients
Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management

Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC.

Eligibility Criteria:
Inclusion Criteria:

• Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study.

Exclusion Criteria:

• Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.
AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal/Well-child Care Model in Pregnancy in Kenya

This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012.

The investigators will carry out a pre/post evaluation of this program comparing maternal and child health indicators collected at the facility and at 10 comparison facilities in the year prior to implementation (2012) and throughout the duration of the program (2013-2014). They will also analyze program attendance records, anonymous exit surveys, and training records.

Eligibility Criteria:
Inclusion Criteria:

* All facilities that participated in AfyaJamii

Exclusion Criteria:

* Any facility that did not offer AfyaJamii and was not been selected as a comparison facility
ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

* Subject is \> 18 years of age.
* Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
* Subject is a candidate for endovascular thoracic aortic repair.
* Subject has a TAA that meets one of the following criteria:
* Is diagnosed with a Fusiform Focal TAA \>5cm, or
* Is diagnosed with a Fusiform Focal TAA that has a diameter \< 5 cm and has exhibited rapid expansion, or
* Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
* Is diagnosed with a saccular TAA of any size.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.

Subject is a candidate for endovascular thoracic aortic repair.

Subject has a TAA that meets one of the following criteria:

1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or
2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
3. Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased\*).

   * Tortuosity and angulation do not exceed 90 degrees.
   * Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.

Exclusion Criteria:

* Subject has a life expectancy \< 2 years.
* Subject has a lesion that prevents safe delivery or expansion of the device.
* Subject has concomitant ascending aortic aneurysm.
* Subject has known allergies to any of the device materials.
* Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
* Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.