cyrilzakka/clinical-trials huggingface dataset:
How Has Glaucoma Affected Your Quality of Life?

Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment worsens in subjects with glaucoma.

Hypothesis 2: Changes in health-related quality of life are associated with changes in clinical measures of vision and performance-based measures of visual function.

You are being asked to participate in this research study because you have glaucoma, which is the second leading cause of blindness in the world and accounts for 15% of blindness worldwide. Vision loss caused by glaucoma can significantly worsen your health-related quality of life. Despite the fact that glaucoma has such a big impact on a large number of people, research examining the long-term effects of glaucoma-related vision loss on one's quality of life is scarce.

The purpose of this study is to look at the long-term effect of this condition on your quality of life so that we may gain valuable information about what factors influence the quality of life of people with glaucoma. To participate in this study, you will need to allow us to perform clinical tests on your eyes, to self-report your well-being and health-related quality of life, and to let us know how well you perform your daily life activities.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or exfoliation glaucoma
* Disk Damage Likelihood Scale stages 5 through 8 with visual field loss
* Age between 21 and 80 years
* Able to understand and speak English

Exclusion Criteria:

* Unlikely to be available for annual ocular examination and reassessment across a 4-year period
* Neurological or musculoskeletal problems that would influence performance on activities of daily living
* Cognitively impaired, as assessed by a face-to-face Mini-Mental State Examination
* Incisional eye surgery within the past three months
* Laser therapy within the previous month
* Any cause for visual reduction other than glaucoma
* Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data
Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.


Eligibility Criteria:
Inclusion Criteria:

* Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
* Symptoms of contact lens discomfort as defined by the protocol.
* Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
* Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Extended (over-night) contact lens wearer.
* Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
* Other protocol-specified exclusion criteria may apply.
Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

The proposed study is a multi-site, three-arm randomized controlled trial of a mindfulness-based intervention for Chinese family caregivers in Hong Kong. Effects of the intervention will be compared with those of an evidence-based psychoeducation program, and treatment-as-usual. 240 caregivers of frail elderly with moderate to severe levels of frailty, will be recruited and randomly assigned to mindfulness-based intervention, psychoeducation, and treatment-as-usual experimental conditions. Overall program effectiveness will be analyzed on measures of caregiver burden, depression, anxiety, positive caregiving experience, spirituality, family conflict, and the biomarker of heart rate variability. Measures on coping styles, experiential avoidance, and self-efficacy will be explored to see if they mediate the changes to participant improvements in outcomes. 6-month follow-up will be included to investigate the maintenance effects.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of frail elderly based on a professional's assessment of Clinical Frailty Scale with a score of 6, indicating a moderate level of frailty or above (Rockwood et al., 2005)
* Caregivers being adult children or children in-law of the elder care receiver
* Caregivers who are experiencing caregiver burden at the time of study, with scores of 8 or above in Zarit Burden Interview-4

Exclusion Criteria:

* impairment, which may present difficulties in comprehending the content of the program
* Spouses, siblings, or friends will be excluded
* Caregivers of elders with moderate to severe dementia will be excluded and the Clinical Dementia Rating Scale will be administered
* Caregivers who had participated in an eight week Mindfulness-Based Stress Reduction or equivalent
The Effects of Surgery for Painful External Snapping Hip

The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for painful external snapping hip
* 18 years or older

Exclusion Criteria:

* Inability to comply with the protocol (e.g. due to dementia)
The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study

An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.

Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.

The following hypotheses were tested:

* The application of additional opiate boli results in significantly lower pain intensity.
* The application of additional opiate boli does not result in a higher rate of adverse Events.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain syndrome
* intrathecal opiate pump
* signed informed consent

Exclusion Criteria:

* younger than 18 years
* other (than opiate) intrathecal drug administration
* discontent with intrathecal opiate therapy
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
* Patients aged ≥20 years on the date of informed consent
* Patients with histologically confirmed diagnosis of one of the following:

  * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
  * Angioimmunoblastic T-cell Lymphoma (AITL)
  * Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)
* Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
* Have at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients with a life expectancy of at least 3 months as determined by the investigator
ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
* Baseline NIHSS \> 5

Exclusion Criteria:

* No intracranial, extravascular blood on CT
* Hypertension (systolic \> 185; diastolic \> 105)
* Baseline fibrinogen level \< 100 mg/dL
* Thrombocytopenia (\< 100,000 / mm3)
* Recent (\< 3 days) or anticipated (\< 5 days) use of a thrombolytic agent
* Recent (\< 14 days) or anticipated surgery
Lymph Node Ratio and Kras Mutation in R Colon Cancer

clinical impact of LN ratio with Kras expression in colon cancer

LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.

Eligibility Criteria:
Inclusion Criteria:

* Stage III colon cancer

Exclusion Criteria:

* Stage I, II, IV
Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity

The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2
* Able to perform exercise testing on a cycle ergometer

Exclusion Criteria:

* Currently taking medications know to affect cardiovascular or respiratory function
* Currently supplementing with an antioxidant compound
* Current smoker
* Currently taking antibiotics
* Not willing to abstain from mouthwash use
* Currently participating in regular physical activity
Cryolesion in Treatment of Phantom Limb Pain

Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.

Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.

Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.

* 24 hours after the procedure - assessment of pain intensity and quality of life
* 7 days after the procedure - assessment of pain intensity
* 30 days after the procedure - assessment of pain intensity and quality of life
* 3 months after the procedure - assessment of pain intensity
* 6 months after the procedure - assessment of pain intensity and quality of


Eligibility Criteria:
Inclusion Criteria:

* Status post amputation of a lower or upper limb
* Pain related to amputation as determined by referring physician and investigator
* Informed consent of patient to enter the study
* Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure

Exclusion Criteria:

* Pregnancy
* Active infection in the area of the planned intervention
* Blood coagulation disorders
* Immunosuppression
* Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
* Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
* Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
* No reduction of pain after the diagnostic block of the relevant main peripheral nerves
A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)

The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
* Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

* Has a history or presence of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)
Evaluation of the Bone Mineral Density and Muscle Mass in Patients Post Coronary Artery Bypass Graft Surgery With Chronic Kidney Disease

The purposes of this study are: (1) to compare the body composition, physical activity, physical function, and quality of life between patients with and without CKD after CABG; and (2) to analyze the relationships among body composition, physical activity, and physical function in this population. It is expected that patients after CABG with CKD have the worse body composition, physical function, and quality of life than patients after CABG without CKD; and patients with higher physical activity levels have the better body composition, physical function, and quality of life.

It has been reported that cardiac disease and renal disease frequently coexisted. Recently, the term cardiorenal syndrome was used to describe the interaction between heart and kidney. Chronic kidney disease (CKD) has become increasingly recognized as an independent risk factor of cardiovascular disease, and the cardiovascular disease is one of most severe complication in patients with CKD. Previous studies have showed the changes in body composition, physical inactivity, decreased physical function, and poor quality of life existed in patients with either cardiovascular disease or CKD. Patients concomitant with cardiovascular disease and kidney insufficiency were expected to significantly increase physical dysfunction. However, few studies addressed on these alterations in patients after coronary artery bypass grafting (CABG) with CKD were reported.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CABG without valve surgery
* chronic kidney disease(matched group: without CKD)

Exclusion Criteria:

1. heart transplantation or redo CABG
2. amputation,
3. cerebrovascular disease or any others disease with limbs dysfunction,
4. lung deficit,
5. cancer,
6. cognitive disorders.
Prognostic Impact of PMI in Stable CAD Undergoing PCI

This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* underwent elective coronary stenting
* patients permit informed consents

Exclusion Criteria:

* acute STEMI
* NYHA class III-IV heart failure
* moderate-to-severe valvular disease
* missing post-PCI troponin results
* active infection, respiratory failure
* liver dysfunction (liver enzyme \>3xURL or bilirubin \>2xURL),
* malignancy and systemic connective tissue disease
* unable to get a informed consents
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).


Eligibility Criteria:
* Inclusion criteria:

  • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.
* Exclusion criteria:

  * Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
  * History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply
Implementation of Apnoea Test for Patients With Suspected Brain Death

This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death.

Although the apnoea test is part of nearly all protocols for determining brain death; implementation significantly differs among intensive care physicians according to national-level acts, national society protocols or local protocols.

This cross-sectional study is based on an international, web-based questionnaire created for intensive care physicians, consisting of 25 questions in English.

The survey will provide a current state of the practice of apnoea testing in patients with suspected brain death. The results can support the determination of future acts to standardize the apnoea test process.

The given answers are anonymous. The e-mail address of the respondent is not recorded. Answers are treated solely for scientific purposes.

Eligibility Criteria:
Inclusion Criteria:

* Physicians working in intensive care units

Exclusion Criteria:

-
A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection

Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity \[IMRT\], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Confirmed histological diagnosis of anal canal squamous cell carcinoma. Basaloid subtype is accepted
* Have underundered serological test for HIV infection
* Any clinical stage

Exclusion Criteria:

* Lack of data on treatments and clinical outcomes
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention

A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis

This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years, inclusive.
2. Body weight \>45 kg.
3. Body Mass Index \>18.5.
4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
5. Only one member in the same household will be enrolled.
6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.

Exclusion Criteria:

1. Pregnant or breast-feeding.
2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
4. Presence of typical COVID-19 symptoms (fever \>38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
5. Hypersensitivity to any component of ivermectin.
6. Participants who have been administered ivermectin within 30 days prior to screening.
7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
10. Current use of monoclonal antibodies for the treatment of COVID-19.