cyrilzakka/clinical-trials huggingface dataset:
Tear Osmolarity Clinical Utility in Dry Eye Disease

Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.

It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.

This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.

Eligibility Criteria:
Inclusion Criteria:

* Dry Eye Symptoms SPEED \>8

Exclusion Criteria:

* Unable to participate in 90 days therapy
* Allergic to therapy
* On medication known to affect ocular surface / tear film
* Had ocular trauma, infection or surgery
* Diagnosed with a medical condition known to affect ocular surface / tear film
Quantitative MR Biomarkers for Sarcoma Treatment

To determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used.

The purpose of this study is to determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used or if it is ineffective early on in the treatment; instead of finding this out 2-3 months later. If it is determined that MRI can accurately diagnose tumor response, medications can be switched early on potentially improv8ing the patients'chances of recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven primary bone or soft tissue tumor
2. No previous treatment for this malignancy
3. Will be given chemotherapy before having surgery or radiation on the tumor.
4. Are able to undergo a MRI examination
5. If your tumor measures at least 1/2 inch in length.

Exclusion Criteria:

1. Younger than 3 yrs. of age or need general anesthesia(sedation that puts you to sleep) to have a MRI performed.
2. History of Renal Failure
3. Are not able to have a MRI performed for any reason such as you have a pacemaker or other implanted device that may malfunction or move because of the magnetic field inside the MRI room and scanner.
4. Have any history of an allergic reaction to gadolinium based contrast agents (a medication injected in a vein that helps create clearer MRI images.

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A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 to 75 years old (man or female)
2. Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
3. Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
4. Refractory or failure of prior therapy
5. Life expectancy greater than or equal to 3 months
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Major organ function has to meet the following criteria:

   * For results of blood routine test (without blood transfusion within 14 days)

     1. HB≥90g/L
     2. ANC≥1.5×109/L
     3. PLT≥180×109/L
   * For results of blood biochemical test：

     1. TBIL\<1.5×ULN；
     2. ALT and AST\<2.5×ULN, but\< 5×ULN if the transferase elevation is due to liver metastases；
     3. Serum creatinine ≤1.25×ULN , or calculated creatinine clearance\>45 ml/min(per the Cockcroft-Gault formula);
8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Allergic to apatinib and docetaxel;
2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), with class Ⅱ and above coronary heart disease, arrhythmia (including QTc lengthened men \> 450 ms, women \> 470 ms) and class Ⅲ-Ⅳ cardiac insufficiency;
3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
4. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; For defecate occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as ulcer type of gastric cancer, and researchers think that may be gastrointestinal hemorrhage;
5. Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency.
6. Patients with symptoms of central nervous system metastasis.
7. Pregnant or lactating women.
8. history of psychiatric drugs abuse and can't quit or patients with mental disorders.
9. Less than 4 weeks from the last clinical trial.
10. The researchers think inappropriate.
Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. Lack of extensive PSA screening in mainland China, many new cases of prostate cancer are LAPCa. Surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. LAPCa is easy to metastasis, relapse and has a poor prognosis. For LAPCa, a single RP approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. However, androgen deprivation therapy promotes the prognosis of LAPCa with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. What is more, for early localized prostate cancer, RT has similar efficacy to RP, for advanced tumor RT can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. A randomized clinical trial comparing two multimodal treatment including RP or RT with ADT regimens is therefore warranted.


Eligibility Criteria:
Inclusion Criteria:

1. 18≤Age ≤75, at the time of randomization.
2. Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
3. Tumor stage (T, M, N): according to 2018 NCCN prostate cancer guidelines T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) Nx (regional lymph nodes cannot be assessed). For patients with T4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded.
4. WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
5. At least 5 years life expectancy.
6. The general condition and mental status of patients shall permit observation in accordance with the study protocol.
7. Signed Informed consent.

Exclusion Criteria:

1. Concomitant with other malignancies.
2. With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
3. Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR \< 30 ml/ml or elevated liver transaminases above \> 10 ULN.
4. Involved in other clinical trials simultaneously.
5. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
CS-101 in Patients With β-thalassemia

The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia.

CS-101 is an autologous CD34+ cell suspension, edited by in vitro base editing technology, which modifies the BCL11A binding site in HBG promoter, so that it loses the ability to bind to BCL11A, which can re-induce the production of γ-globin chain and increase the concentration of fetal hemoglobin(HbF) in the blood, compensating for the function of missing adult hemoglobin HbA to achieve clinical cure. The therapy addresses two major challenges in the current treatment of the disease: lack of matching donors and graft-versus-host diseases in allogeneic hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 35 years old(inclusive) male or female subjects at the time of informed consenting Diagnosis of β-thalassemia, genotypes include but are not limited to β+β0，βEβ0，β0β0, etc History of at least≥8 units/year of packed RBC transfusions in the prior 12 months prior to the screening period Generally in good condition, Karnofsky performance score≥60 points for subjects≥16 years old at the time of autologous hematopoietic stem cell collection, or Lansky Play-Performance score≥60 points for subjects under 16 years old, or equivalent clinical evaluation as the investigator site's common practice

Exclusion Criteria:

* Treatment with other investigational medications or other experimental interventions 30 days prior to signing informed consent or within 6 half-lives of the drug, whichever is longer.

Subjects who have received or are receiving thalidomide and/or Luspatercept, when their drug-drug interaction on the efficacy and safety of CS-101 cannot be ruled out, unless at least there are 3 test results showing the total hemoglobin level before transfusion is below 9g/dL in the past 6 months before screening.

Previously received allogeneic hematopoietic stem cell transplantation or gene(edited) therapy.

Subjects have available related fully matching donors and are eligible and prepared for allogeneic hematopoietic stem cell transplantation.

Those with active infections, including but not limited to: HIV, hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus and treponema pallidum test positive, or known tuberculosis, parasitic infection, etc. who are judged by the investigator to be unsuitable to participate in this study.

Echocardiography results with ejection fraction below 45%. Advanced liver disease, defined as：

Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) or:

Baseline International Normalized Ratio (INR) \>1.5 × ULN.

MRI during the screening period showed heavy iron overload and is judged by the investigator to be unable to participate in the study.
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes

This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes mellitus type 2
Muscle, Essential Amino Acids, and eXercise in Heart Failure

Half of heart failure patients have preserved ejection fraction (HFpEF). Like patients with reduced ejection fraction (HFrEF), HFpEF patients suffer from exercise intolerance (low VO2max), which reduces physical function, quality of life, and survival. Strikingly, there is no medication proven to increase survival for HFpEF patients. Whereas exercise intolerance in HFrEF patients is the result of cardiovascular limitations, physical dysfunction in HFpEF patients is largely the result of peripheral abnormalities in skeletal muscle. Indeed, research in HFpEF patients identified that physical function and VO2peak are directly related to leg lean mass, and drugs focused on improving cardiovascular function have failed to improve VO2peak. Unfortunately, no therapy has been identified for this population that can concurrently improve cardiovascular and muscle health. The need for improved muscle therapies is reinforced by the fact that HFpEF patients are commonly older adults who are predisposed to muscle wasting. Strategic essential amino acid (EAA) ingestion has been shown to improve the adaptive response of muscle to exercise. Therefore, the investigators will determine, in HFpEF patients, the extent to which ingesting a strategic mixture of EAAs during an acute aerobic exercise training program enhances the response to this exercise strategy.


Eligibility Criteria:
Inclusion Criteria:

* Age 60+ years of age
* Able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
* Diagnosed with HFpEF as per established echocardiographic criteria (New York Heart Association Class II-III).

Exclusion Criteria:

* Unstable angina, myocardial infarction in the past 4 weeks
* Uncompensated heart failure
* New York Heart Association class IV symptoms, complex ventricular arrhythmias, symptomatic severe aortic stenosis, acute pulmonary embolus, acute myocarditis, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, baseline blood screening abnormalities
* Medication non-compliance
* Medical / orthopedic conditions precluding exercise
* Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
* Subjects on anti-coagulation medication will not be eligible for the muscle biopsy procedure, but are deemed eligible for study participation if INR \< 3.
First Australian National Trans Mental Health Study

This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years and older living in Australia. This population has received limited attention from public health researchers, planners, and practitioners. However, a growing body of evidence suggests that trans people experience disparities in several important areas of health compared with the population generally. In particular, trans people are more likely to experience mental health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit drugs, and think about or attempt suicide. Additionally, trans people commonly report that their physical and mental health needs are not met, and underutilise preventive health care.

Participants were recruited using several non-probability sampling techniques, (including purposive sampling and snowball sampling), because random sampling is not possible with this population. Medical, social, support, and advocacy networks used by trans people were used to promote the study. A mixed quantitative and qualitative methodology was used. Validated quantitative instruments were used to obtain measures of health and well-being, which will be compared against population norms. Qualitative items complement these measures, providing rich experiential data.

The investigators hypothesised that:

* the prevalence of depressive and anxiety disorders will be higher than for the population generally, and that these conditions will commonly be undiagnosed and untreated;
* depressive and anxiety disorders will be associated with risky behaviours, such as tobacco, alcohol, and illicit drug use; and,
* trans people will report poor relationships with medical practitioners.

The investigators hypothesised that poor mental health is a consequence of several interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing medical treatment to alter sexual characteristics); societal discrimination and stigma (including harassment and violence); institutionalised discrimination (including difficulty changing identifying documents, and exclusion of surgical procedures and related treatments from public and private health systems); social isolation; and the belief held by many clinicians that transsexualism is a mental disorder (which may be a barrier to trans people forming trusting relationships with medical practitioners).


Eligibility Criteria:
Inclusion Criteria:

* Live in Australia
* Self-identify as trans

Exclusion Criteria:

* Aged less than 18 years
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
2. Currently treated with levodopa at a minimum dose of 300 mg/day
3. Montreal Cognitive Assessment (MOCA) ≥15
4. Demonstrated capacity to provide informed consent.
5. 40-90 years of age
6. Estimated glomerular filtration rate ≥60
7. Absence of uncontrolled hypertension in medical history
8. Absence of insulin use

Exclusion Criteria:

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Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Primary:

* To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks)

Secondary:

* To evaluate the percentage of patients with DBP \< 90 mmHg at 6 and 12 weeks
* To evaluate the percentage of patients with SBP \< 140 mmHg at 6 and 12 weeks
* To evaluate rate of adverse events during the study


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate hypertension (90mmHg\<DBP\<110mmHg and 140mmHg\<SBP\<180mmHg)
* Or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet
* Or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion
* A minimum exam labs as required by WHO-ISH within the month before the inclusion

Exclusion Criteria:

* Severe Arterial Hypertension (PAS \> than or = to 180 mm Hg or PAD \> than or = to 110 mmHg)
* Isolated Systolic Hypertension
* Secondary Hypertension
* Bilateral renal arterial stenosis or renal arterial stenosis
* Non surgically sterilised woman or non post-menopausal woman
* Confirmed sodium depletion
* Irbesartan hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Delivery of "Doing What Matters in Times of Stress: An Illustrated Guide"

The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. The informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 Turkish and 64 Syrian) participants who meet the inclusion criteria will be included in the feasibility study. The psychological problems will be measured twice, before and after the intervention.

Studies about the impact of epidemics such as Severe acute respiratory syndrome (SARS) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. Today, studies on the effects of COVID-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics.

The aim of this project is to deliver the "Doing What Matters in Times of Stress: An Illustrated Guide" that is developed by the World Health Organization within Self Help Plus (SH+) intervention to decrease their psychological problems for a feasibility study. The feasibility study for the delivery of the SH+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results.

The most important contribution of the Project is conducting a feasibility study with the "Doing What Matters in Times of Stress: An Illustrated Guide" which will be adapted to the Turkish culture based on the determination of Turkey's current psychological status, provide a form of intervention to the Turkish psychological intervention literature and to improve the psychological status of the participants in this project.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or above
* Being literate
* Being a Turkish citizen or a Syrian refugee
* Scoring 15 or above on Kessler Psychological Distress Scale (K10)

Exclusion Criteria:

* Imminent suicidal risk
* Being illiterate
Triton Reference Database

The objective of this study is to collect OCT measurement data on normal healthy eyes.

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon DRI OCT Triton based on the percentile points for 1%, 5%, 95%, and 99%.

Eligibility Criteria:
Inclusion Criteria

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better bilaterally

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%
4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:

   1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
   2. Glaucoma hemi-field test "outside normal limits."
5. Narrow angle
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine