cyrilzakka/clinical-trials huggingface dataset:
Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes

High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
2. Morphologic manifestation in OCT shows split between retinal layers in macular area.
3. Patients without severe systemic disease and can tolerate surgery.

Exclusion Criteria:

1. Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
2. Patients with nystagmus or have difficult to open the eye.
3. Patients with severe systemic disease and cannot tolerate surgery.
The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer

Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further.

This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.


Eligibility Criteria:
Inclusion Criteria:

* Have had an orchiectomy OR;
* Are receiving a GnRH agonist/antagonist OR;
* Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide
* Long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months).

Exclusion Criteria:

* Patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (Note: Patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project).
* Patients who are stratified as high risk for having a cardiovascular event.
* Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician.
* Men with painful or unstable bony metastases.
Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* age 10-13 years (inclusive)
* diagnosis of T1DM for at least one year
* fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
* utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
* current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.

Exclusion Criteria:

* clinical or laboratory characteristics suggestive of type 2 DM
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
* current participation in another study that may impact glycemic control
* HbA1c \>14% (because these individuals may need a more intensive intervention than this is intended to provide)
* lack of a computer or compatible cell phone for uploading CGM or glucometer data.
Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.

Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Absolute CD4 count of 200 - 500 cells/mm3.
* No active opportunistic infection or Kaposi's sarcoma.

Prior Medication:

Allowed:

* Prior ddI for no longer than 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Lymphoid malignancy.
* Pancreatitis.
* Peripheral neuropathy.
* Critical illness.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than ddI.
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.
* 1-Thyroxine.

Concurrent Treatment:

Excluded:

* Radiotherapy.

Prior Medication:

Excluded within 1 month prior to study entry:

* Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total).
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.

Prior Treatment:

Excluded:

* Radiotherapy within 1 month prior to study entry. Active drug abuse.
Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World Health Organization Classification, stages II-IV or limited stage I disease that is bulky (more than 10 cm) or with International Prognostic Index (IPI) score \> 1.
* 2. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A short course (\< 2 weeks) of corticosteroids is allowed.
* 3. Adequate paraffin-embedded tumor specimen must be available for gene expression analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is deemed inadequate, the subject can be retroactively screen failed, as this does not change the treatment regimen).
* 4. Baseline measurements and evaluation must be obtained within 4 weeks before first treatment.
* 5. Age \>18 years.
* 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
* 7. Adequate organ function:

  * White Blood Cells count (WBC) \>2500/µL
  * Absolute Neutrophil Count (ANC) \> 1000/µL (unless due to disease in marrow)
  * platelet count \>100,000/µL (unless due to disease in marrow)
  * creatinine \< 2.0 mg/dL,
  * bilirubin \< 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by lymphoma)
  * Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) \<3 x upper limit of normal.
* 8. Female patients must not be pregnant or breast feeding.
* 9. Women of childbearing potential and men must be strongly advised to use an accepted and effective method of contraception.
* 10. Patients must have left ventricular ejection fraction of \>45%.
* 11. Provision of written informed consent.

Exclusion Criteria:

* 1. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least two years previously; and; the patient continue to be free of evidence of recurrence.
* 2. Patients with HIV infection as these patients are managed on dedicated protocols.
* 3. Patients with active central nervous system (CNS) lymphoma.
Effectiveness of Cane in Osteoarthritis (OA) Patients

Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.

Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

Eligibility Criteria:
Inclusion Criteria:

* Primary Knee osteoarthritis (ACR criteria)
* VAS for knee pain between 3 and 7
* No changes the NSAID intake or physical activity in the previous 3 months

Exclusion Criteria:

* Symptomatic heart or pulmonary disease
* Severe systemic disease
* Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
* Joint injection in the previous 3 months
* PT in the previous 3 months
* Previously cane use
* Start regular physical activity in the last month
Enhanced Detection in Glioma Excision

The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Female patients are not pregnant at time of surgery.
* Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.

Exclusion Criteria:

• Participants are participating in another trial at time of operation
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.

This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot

This is a Post-Marketing, Multicentre, Open, Randomized Phase 4 Clinical Study. Subjects who gave voluntary written informed consent to participate in the study were screened for eligibility in the study, and those who met the eligibility criteria were randomized in the investigational group.

An investigator assessed the effectiveness (immunogenicity) and safety of the study vaccine in each subject during his/her participation in the study.

Subjects were randomized (Visit 1) into the investigational group according to a randomization table previously generated, and were vaccinated with influenza split vaccine, 'GC FLU®Pre-filled Syringe Injection' and 'GC FLU®Injection'.

12 Assessments for HI titre to each strain of influenza were performed at Visit 1 (pre-vaccination), and at Visit 3 (21 days after vaccination) for the efficacy (immunogenicity) evaluation \[Picture 1\].For the safety assessment, subject diaries were handed out to subjects, who were instructed to record any adverse event emerging ager the receipt of study vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults≥ 18 and \< 65years of age who can be followed up for 21 days.

Depending on the part of the study that a subject was going to participate, age criteria were further divided as follows:

Lot-to-lot consistency study \[PART A\]: ≥ 18 to \< 65 years of age Annual clinical trial \[PART B\]: ≥ 18 to \< 65 years of age \[adults\]

* 65 years of age \[elderly population\]

  * Subjects who gave voluntary written consent to participate in the study, and are able to comply with the study requirements.

Exclusion Criteria:

* Subjects with a known hypersensitivity of allergic reaction to eggs or egg products, to chicken or chichenproducts, to any component of the study vaccine, neomycin or gentanicin.
* Subjects with immune system disorders, including immune deficiency disease.
* Subjects with a history of Guillain-Barre syndrome.
* Subjects with severe chronic disease (e.g., cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy, etc.) who in the investigator's opinion may have difficulty in participating in the study.
* Subjects with haemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
* Subjects who had acute fever with the body temperature exceeding 38.0 °C within 72 hours before vaccination with the study drug.
* Subjects who had received other vaccinations within 7 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
* Subjects who had received immunosuppressant or immune modifying drug within 3 months before vaccination with the study drug.
Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia

This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

OBJECTIVES:

I. The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.

OUTLINE: Patients are randomized 1 of 2 treatment arms.

All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.

ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.

ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Absolute neutrophil count \< 500 cells/mm\^3 or \< 1000 cells/mm\^3 with a predicted decrease to \< 500 cells/mm\^3
* Temperature \> 38.0 degrees Celsius
* Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
* Cefepime prescribed at a dose of 2 grams IV every 8 hours

Exclusion Criteria:

* Allergy to a cephalosporin antibiotic
* Estimated creatinine clearance \< 50 milliliters/minute
* Concurrent anti-gram negative antimicrobials
* Diagnostic criteria suggestive of sepsis
* Circumstances which may make 3 hour infusion impractical
* Solid tumor malignancy
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI

The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment (MCI).

This multilevel study will be comprised of a placebo controlled randomized controlled trial to test the effect of long-term (6 months), multi-domain, computerized cognitive training on large-scale structural and functional brain networks in individuals with MCI (age \>= 65 years). Neuroimaging and neuropsychological data before and after intervention will be evaluated within and between groups to elucidate the trajectory of neuronal network improvements associated with training compared to typical MCI development. We will compare the outcomes between participants with MCI who receive structured cognitive training (treatment group: TG) with those who receive nonspecific computerized training activities (active controls: AC). The duration of intervention is 6 months. The focus of the study will be on individuals with amnestic MCI (single- or multi- domain). The study includes 30 MCI subjects in a treatment group (TG) and 30 matched MCI subjects in active control (AC) group. TG and AC participants will be evaluated at two time points: 1) baseline and 2) 6-month (post-training).

Eligibility Criteria:
Inclusion criteria:

* Cognitive concern by subject, informant or physician
* Impairment in memory domain (delayed recall of one paragraph from Logical Memory II subscale from Wechsler memory Scale - Revised with cutoff scores of \<=8, \<=4 and \<=2 for 16, 8-15 and 0-7 years of education)
* Essentially normal functional activities
* Mini-Mental State Examination (MMSE) scores \>=24
* Stability of permitted medications (e.g. cholinesterase inhibitors, hypertension medication, etc.) for at least two months.

Exclusion criteria:

* Any significant neurological condition including probable dementia, Parkinson's disease, Huntington's disease, multiple sclerosis, and brain tumor, among others.
* Presence of Axis I disorder
* Current use of psychoactive medications except for the permitted medications.
* Claustrophobia
* MRI contraindication
* Any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol.
Sleep Impairment and Coping Style in Diabetes

To examine the effect of sleep impairment on coping style of patients with diabetes

Abstract Objective: To examine the effect of sleep impairment on coping style of patients with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping Style Inventory.

Eligibility Criteria:
Inclusion Criteria:

- Patients with diabetes longer than 6 months

Exclusion Criteria:

- Complications as a congestive heart failure, chronic renal failure
Investigating Hearing Aid Frequency Response Curves 2

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality and listener comfort. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music and while in different listening enviroments.

Eligibility Criteria:
Inclusion Criteria:

* N3 - N5 Hearing losses
* Healthy Outer ear
* No visible congenital or traumatic deformity of the outer ear
* Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
* Ability to answer questions and repeat sentences
* No history of problematic tinnitus or pain/discomfort from loud sounds
* No history of active drainage from the ears in the past 90 days
* Willingness to wear different styles of couplings
* Willingness to wear binaural fitting
* Experienced Users = more than 3 months of hearing aid experience
* Ability to travel to Sonova facilities

Exclusion Criteria:

* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
* Limited mobility/not able to come to the scheduled visit
* Inability to produce reliable hearing test results
* History of active drainage from the ear in the previous 90 days
* Abnormal appearance of the eardrum and ear canal.
Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer. However, changes in the patients metabolism are usually seen as a result of hormone therapy. These changes include increased fat mass, decreased lean mass, weight gain, high blood cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac events such as heart attack. The researchers of this trial would like to learn if these change in body mass are affected by the presence of brown fat in the body. Brown fat is made up of fat cells that are stored in the body and generate heat to control body temperature. Levels of brown fat are at the highest in newborn babies and decrease over time into adulthood. The researchers of this trial would like to learn more about these changes in metabolism during prostate cancer treatment by studying the changes in brown fat during the first 12 months of hormone therapy.

* Participants will be asked to come into the clinic for additional visits before they begin hormone therapy. The following procedures will be performed: Cold-activated PET/CT scan; body composition DXA scan; blood tests, questionnaires and abdominal fat biopsy.
* During hormone therapy, the participant will return to the clinical once after 3 months, and again after 6 months, to draw blood for laboratory tests.
* After 12 months of hormone therapy, the participant will return to teh clinic to repeat the following procedures: Cold-activated PET/CT scan; body composition DXA scan; blood tests; questionnaires and abdominal fat biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Scheduled to initiate GnRH agonist or antagonist treatment with an intended treatment duration of 12 months or greater
* ECOG Performance status of 0 or 1
* Ability to understand and the willingness to sign a written informed consent
* 65 years of age or younger

Exclusion Criteria:

* Diagnosis of diabetes
* Ongoing corticosteroid use
* GnRH agonist or antagonist treatment within the last 2 years
* Ongoing beta-blocker use
* Body mass index of greater than 30