cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined with Androgen Deprivation for Prostate Cancer

The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).

The purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into two groups, homoharringtonine combined with androgen deprivation and placebo combined with androgen deprivation, according to a computer-generated random sequence. Treatment group was given 1mg intravenous infusion of homoharringtonine + 250ml 5% glucose injection, once a day for two consecutive days, and repeated medication after three weeks of intermittent treatment for two cycles + continuous androgen deprivation therapy; In the placebo group, the same size, color, and dosage form of 5% glucose injection were used, and the administration was the same as in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Eligibility Criteria:
Inclusion Criteria:

* ① Age ≥18 years and ≤85 years;

  * Histologically confirmed prostate cancer without small cell features;

    * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;

Exclusion Criteria:

* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.

  * Previous prostatectomy;

    * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient

      * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Effectiveness of a Functional Literacy Program for Formerly Homeless Adults

The purpose of this study is to assess a functional literacy program for formerly homeless adults now residing in supported housing who have difficulty performing daily life skills requiring functional literacy (e.g., bill paying, medication management, community transportation) needed to maintain housing placements. The hypothesis is that intervention group participants will improve in functional literacy compared to the control group that does not receive the intervention.

Sixty-five percent of homeless adults are reported to be illiterate or marginally literate. The lack of literacy in a high technological society negatively impacts this population's ability to participate in daily life activities including finding and maintaining employment, renting and maintaining an apartment, seeking health care, using public transportation, and managing finances. Poor literacy marginalizes this population from societal participation and maintains this group in a state of lack and deficiency.

A literacy program will be delivered to participants who are formerly homeless and now residing in supported shelter. Participants will be randomly assigned to an intervention (n=20) or control (n=20) group. The intervention group will receive the functional literacy intervention over 8 weeks, twice weekly. Intervention sessions will allow participants to learn literacy skills within the context of real-life daily activities like grocery shopping, preparing a meal, and purchasing subway cards. Control group participants will not receive intervention.

Eligibility Criteria:
Inclusion Criteria:

* Resident of a supported shelter environment (after homelessness)
* Self-reported difficulty with basic reading skills needed to participate in desired daily life activities
* English-speaking

Exclusion Criteria:

* Severe behavioral management disorder that would make cooperation and direction following problematic
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole


Eligibility Criteria:
Inclusion Criteria:

* Primary Restless Legs Syndrome (i.e. idiopathic RLS)
* Indication for treatment with pramipexole
* Male or female patients older than 18 years

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
* Current treatment with pramipexole
Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-30 kg/m2

Exclusion Criteria:

* Taking drugs or functional food that may affect body weight or body fat
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* History of severe disease and/or major surgery
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.


Eligibility Criteria:
Inclusion Criteria:

* Adapted soft contact lens wearer;
* Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
* Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
* Correctable to 6/9 (20/30) in both eyes;
* Read, understand, and sign the informed consent;
* Willing to comply with the wear schedule;
* Willing to comply with the study visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any active corneal infection, injury or inflammation;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Systemic or ocular disease which might interfere with contact lens wear;
* Strabismus or amblyopia;
* Corneal refractive surgery and any anterior segment surgery;
* Use of systemic/topical medication contraindicating contact lens wear;
* Use of gas permeable contact lenses within 1 month preceding the study;
* Participation in any concurrent clinical trial or in the last 30 days;
* Other protocol-defined exclusion criteria may apply.
IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY

Identify by culture the urinary microbiota of patients with bladder cancer (at the time of diagnosis) and controls.Identify by metagenomics the urinary microbiota of patients with bladder cancer (at the time of diagnosis) and controls.

Relationships between the human microbiota and various pathologies such as cancer have been demonstrated. The microbiota would have an influence on the effectiveness of anticancer treatments.

Bladder cancers are five times more common in men than women, and this difference in incidence has long been explained by a higher smoking rate among men. However, the increase in smoking among women has not led, as in the case of lung cancer, to a significant increase in bladder cancer among them.

Urine bladder has long been considered "sterile" by generations of researchers. Recent studies have shown that most urine is not sterile but instead contains a different microbiota in both men and women. In women Actinobacteria, including Mycobacteria, and Bacteroidetes have been detected.

BCG therapy is used in the treatment of bladder cancer. BCG, in addition to being a vaccine to prevent tuberculosis, is a mycobacterium belonging to the phylum Actinobacteria \[4\]. Controversial studies have suggested the same potential for Lactobacillus casei. Lactobacillii are Firmicutes found both in the urinary microbiota of men and women.

Thus microbiota composed mainly of Actinobacteria could be associated with a lower incidence of bladder cancers in women.

Eligibility Criteria:
Inclusion Criteria:

* Person receiving a cystoscopy in the context of a suspicion of bladder cancer
* Person and / or legal guardian for minors who have been informed about the study and have not expressed opposition to participate in the study.
* Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

* Vulnerable person: pregnant, parturient or nursing woman,
* person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision.
* Person treated with antibiotics
Comparison of Ultrafast Echo With Echotracking

The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.

Ultrafast ECHO is a new non invasive method for assessing stiffness of living tissues. It takes advantage of very fast imaging technologies (up to 20 000 images/sec) to measure the diffusion of pressure waves in the tissues. This pressure wave can be either natural (blood pressure), or generated by an very short ultrasonic impulsion at a given place. By using both modes, it is possible to have a precise cartography of tissue mechanical properties. This technique is applied to solid tissues such as breast or liver, but not yet currently to hollow tissues such as arteries. The aim of the present study is to compare the values of stiffness obtained with Ultrafast ECHO with the reference non invasive technique, the Echotracking, which measures stiffness by assessing the deformation of arteries in response to changes in blood pressure. On the physiological part, we will revisit old concepts of increased stiffness of hypertensive's arteries. Indeed, hypertension is associated with increased stiffness due to recruitement of collagen fibers, but also to chronic remodelling. We have shown before that this remodelling conducts to accumulation of arterial tissue of lesser intrinsic stiffness. The latter finding was done through models based on echotracking measurements. It will be interesting to see whether it holds true when stiffness is directly measured.

Sixty subjects (30 normotensive and30 hypertensives) will be included and studied once. Measurement will be performed in random order 3 time on the common carotid artery on both sides. Aortic stiffness will be measured by pulse wave velocity

Eligibility Criteria:
Inclusion Criteria:

* hypertension,
* essential (WHO workup),
* untreated (\> 28 days of treatment interruption, \< 6 months of treatment) on insufficiently equilibrated (BP \> 140 and/or 90 mmHg)

Exclusion Criteria:

* Any concomitant severe disease compromising patient's participation or compliance
Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain

The purpose of the present study is to determine the association between factors known to be associated with the development of chronic low back pain (psychological and biological) and the evolution of functional disability in individuals with a history of low back pain. To do so, 100 individuals with a history of nonspecific low back pain will be followed over a period of 18 months. During this time frame, participants will be evaluated three times in the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for functional disability and pain intensity levels of their low back pain as well as for psychological symptoms usually associated with the development of chronic low back pain. It is hypothesized that high psychological symptoms measured initially will be associated with high functional disability throughout the study .


Eligibility Criteria:
Inclusion Criteria:

* To have experienced at least one episode of disabling (resulting in loss of work or modified tasks at work) nonspecific low back pain in the past three years.

Exclusion Criteria:

* Specific causes of low back pain, arthritic conditions, other chronic pain conditions
A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects

The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial

Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were randomized in two groups of thirty subjects each. The skin prick test with histamine was performed on the ventral forearm, 10 cm from the elbow, before and after supplement administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or placebo(35g/day)intake.

Eligibility Criteria:
Inclusion Criteria:

* Histamine skin prick test: above 3mm

Exclusion Criteria:

* No medication or cosmetic creams were allowed during Substances the previous week and no drugs containing corticosteroids or ACTH within 3 months.
* Patients on systemic or topical treatment with immunosuppressive agents on the nondominant arm were excluded
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

The purpose of this study is to determine the effect of orally given paracetamol on the vascular function and on 24-hour blood pressure in patients with coronary artery disease

Patients with chronic pain diseases (e.g. osteoarthritis) are dependent on effective medication. NSAIDs are very effective in lowering pain in these patients. Recently there has aroused major concern with regard to cardiovascular side effects and safety, especially in selective cyclooxygenase-2 inhibitors (coxibs) but also in "regular" NSAIDs.

At the moment, there is a big confusion, whether these drugs still should be used, especially in patients with known coronary artery disease. Physicians now try to switch to high dose paracetamol, despite the weaker efficacy in pain relieve, because this drug is considered generally as not harmful.

As there is very few information on the cardiovascular effect of this drug, we plan to perform this study and investigate the impact of paracetamol on endothelial function, an important cardiovascular surrogate marker, on inflammatory markers and on oxidative stress in patients with coronary artery disease on top of standard medication, including aspirin

Eligibility Criteria:
Inclusion Criteria:

* Age: 30 - 80 years
* History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
* Stable cardiovascular medication for at least 1 month
* Written obtained informed consent

Exclusion Criteria:- myocardial infarction, unstable angina, stroke within 3 months prior to study entry

* coronary intervention/revascularisation procedure within 3 months prior to study entry
* Left ventricular ejection fraction \<50%
* Other analgesics (Platelet inhibition therapy with Aspirin 100mg/d will be continued)
* Long acting nitrates
* Smoking
* Chronic heart failure (\> NYHA II)
* Ventricular tachyarrhythmias
* Renal failure (serum creatinine \>200umol)
* Liver disease (ALT or AST \>100 IU), especially acute hepatitis
* Hyperbilirubinemia
* Alcohol abuse
* Oral Anticoagulation
* Concomitant therapy with Phenobarbital, Phenytoin, Carbamazepin, Isonicotinic Acid, Chloramphenicol Chlorzoxazone, Zidovudine, Salicylamide
* Insulin-dependent diabetes mellitus
* Drug abuse
* Anemia (Hb\<10 g/dl)
* Known allergies on Paracetamol
* Pregnancy
* Malignancy (unless healed or remission \> 5 years)
* Symptomatic hypotension, hypertension \>160/100 mmHg
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.

Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 Diabetes mellitus
* Peripheral neuropathy
* Stabilized on pain medication for at least one month
* No previous invasive intervention for pain relief

Exclusion Criteria:

* Local wound or skin abnormality in the applicable area
* Allergic to capsaicin
* Refuse to participate or give consent
* Has other significant disease or receive medication that may worsen neuropathy
Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects with Diabetic Macular Edema

This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* BCVA of ≥ 24 and ≤ 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400)
* Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy.
* DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and spectral domain-optical coherence tomography (SD-OCT)
* Mean foveal thickness of at least 300 µm by SD-OCT
* Ability and willingness to comply with the treatment and follow-up procedures
* Ability to understand and sign the informed consent form
* Intraocular pressure of ≤ 21 on 2 or less IOP lowering medications

Exclusion Criteria:

* Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc.)
* Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery system
* Any ocular surgery in the study eye within 12 weeks of screening
* Any history of vitrectomy in the study eye
* Aphakia in the study eye
* Presence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of \>1.5 mm2 on OCT-Angiography
* Prior intraocular or periocular treatment for DME
* Macular laser for the treatment of diabetic macular edema within 12 weeks of screening
* Any change in systemic steroidal therapy within 3 months of screening
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* History or presence of viral disease of the cornea or conjunctiva
* History or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment.
* Any lens or corneal opacity which impairs visualization of the posterior pole
* Participation in another clinical trial within 12 weeks before the screening visit or during the study
* Expectation that subject will be moving away from the area of the clinical treatment center without the ability to return for visits within the study period
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.

Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.

This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features after the somministration of Tadalafil 20 mg orally for more than 6 months.

Eligibility Criteria:
Inclusion Criteria:

* age older than 45 years
* diagnosis of erectile dysfunction due to surgery of radical prostatectomy
* treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
* absence of diabetes, heart diseases, hypertension
* absence of drug intake
* absence of vitreoretinal, vascular retinal diseases
* absence of previous ocular surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria:

* age younger than 45 years
* diagnosis of erectile dysfunction due to other causes
* previous treatments before Tadalafil for erectile dysfunction
* presence of diabetes, heart diseases, hypertension
* drug intake
* vitreoretinal and vascular retinal diseases
* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images