cyrilzakka/clinical-trials huggingface dataset:
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

To facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. This test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. This makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable.

To overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine.

In our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy.

If our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.


Eligibility Criteria:
CASES Inclusion criteria

Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the group of cases:

* Bladder cancer
* Urethral tumor
* Renal Pelvis Tumor
* Ureteral tumor

The exclusion criteria will be:

* Age under 18
* Pregnancy
* Lack of informed consent
* Persons with indwelling catheter
* Presence of prostate cancer
* Presence and / or history of renal cancer, except tumors of the renal pelvis

CHECKS Inclusion criteria

Patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the control group:

* Kidney, ureteral or bladder stones
* BPH

The exclusion criteria will be:

* Age under 18
* Pregnancy
* Lack of informed consent
* Indwelling Catheter wearers
* Presence of prostate cancer
* Presence of kidney cancer, including kidney pelvic tumors
* Presence and / or history of ureteral cancer
* Presence and / or history of bladder cancer
* Presence and / or history of urethral cancer
Psychiatric Day Hospital Treatment

The aim of the study was to compare the effectiveness of acute psychiatric day care to conventional inpatient care within a cross-national multi-site randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have presented with a mental disorder with current symptoms that had either led to at least a moderate disturbance in performance in more than one area of daily living or had jeopardized the residential, financial or occupational status of the patient or his family
* Treatments other than inpatient or day hospital care must have been inadequate or not sufficiently effective for the patient's current mental state

Exclusion Criteria:

* Temporary admission for diagnostic purposes or for other reasons
* Under 18 or over 65 years
* Admission without consent of the patient (according to country-specific legal regulations)
* One-way journey to hospital longer than 60 minutes
* Suicidal risk
* Risk to others
* Degree of severity of the disorder requires measures restrictive of the patient's freedom on the day of admission, or a 1:1 supervision, or deems such probable
* Acute intoxication
* Main clinical diagnosis: addictive disorder
* Presence of a somatic disorder requiring inpatient care
* Direct transfer from a different hospital
* Homelessness
* Need for constant pick-up and delivery service
* Inability to give informed consent with respect to participating in the study
Injecting Drug Use Community Intervention Trial

The purpose of this study is to reduce the HIV/HCV incidence among the clients attending community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual transmission from HIV+ clients to their spouse and sex partners, through intensified comprehensive intervention.

Even though National sentinel surveillance data show that the increase rate of HIV new infections among IDUs in China has become stabilized and slowed down, the new HIV infection is still on the rise, especially in the Yunnan, Guizhou, Guangxi, Xinjiang and Sichuan. This study attempts to further reduce the new infection among MMT clients, and particularly to prevent the transmission from HIV infected clients to their sexual partners with comprehensive intervention.

The purposes of this study are:

1. To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.
2. To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.

Eligibility Criteria:
(1) For MMT clients:

Inclusion Criteria:

* 20 years or above and have independent capacity of civil conduct.
* Those have enrolled in MMT clinics more than one month, and progressed to the phase of maintenance treatment.
* No mental and other physical diseases
* More than 6-month stay at local places and registered at the designated clinics.
* Complete Informed consent

Exclusion Criteria:

* Fail to complete Informed consent
* Temporarily transit in or out of the designated clinic.
* Those have enrolled in MMT clinics less than one month, and haven't progressed to the phase of maintenance treatment.
* With serious mental or other physical diseases

For the spouse or sex partners of MMT HIV+ clients'

Inclusion Criteria:

* 20 years or above and have independent capacity of civil conduct.
* Keep fixed sexual contact with HIV+ clients in the recent 6 month
* No mental and other physical diseases
* More than 6-month stay at local places and be able to participate the 1 year follow up.
* Complete Informed consent
* The recent HIV test is negative

Exclusion Criteria:

* Fail to complete Informed consent
* Temporarily transit in or out of the designated clinic.
* With serious mental or other physical diseases
* The recent HIV test is positive
A Comparison of the Effect of Dorzolamide and Timolol on Optic Disk Blood Flow in Patients With Open Angle Glaucoma

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disk damage and concommitant visual field loss. However, recent investigations show that IOP is not necessarily an adequate measure of clinical severity or a predictor of clinical progression: about 20% of all eyes with high IOP do not develop visual field loss and some patients suffering from visual field loss due to optic disk damage have normal IOP. Hence, factors other than IOP are likely involved in the pathogenesis of glaucoma. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention and optic nerve head hypoperfusion may play a critical role in the development of glaucoma. It may therefore be important for an optimal prevention of visual field defects in glaucoma that the topical antiglaucoma drugs used do not only reduce IOP but also stabilize or enhance the perfusion of the optic nerve head.

Therefore, the aim of the present study is to compare the effect of a 3 months treatment with timolol or dorzolamide in patients with open angle glaucoma on optic disk blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 19 years
* Primary open angle glaucoma or ocular hypertension with IOP higher than 22 mmHg in at least one eye
* Washout period for previous antiglaucoma treatment: two weeks for adrenergic agonists, one week for parasympathomimetic agents

Exclusion Criteria:

* Exfoliation glaucoma, pigmentary glaucoma
* History of acute angle closure
* Intraocular surgery or argon laser trabeculoplasty within the last 6 months
* Ocular inflammation or infection within the last 3 months
* Contact lenses
* Patients with bradycardia (heart rate less than 50 beats/min)
* Second or third degree heart block
* Asthma
* COPD
* Congestive Heart Failure
* Severe renal impairment (Creatinine clearance less than 1.8 l/h
* History or hypersensitivity to one of the study drugs or drugs with similar chemical structure
* History of non-IOP responder to beta-blockers or carbonic anhydrase inhibitors
* Pregnancy
Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients on Tamoxifen Using a Wrist-worn Internet of Things Device

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.

Breast cancer is the most common malignant tumors occurring in women worldwide. Treatments include surgery, radiation therapy, chemotherapy, hormone therapy, and target therapy. As multidisciplinary treatment improves breast cancer survival, there is a growing interest in the quality of life of breast cancer survivors. Common symptoms that patients with breast cancer continue to complain of during or after their treatment include fatigue, pain, depression, sleep disorders, weight gain and hot flashes.

There are only a few studies investigating sleep problems in breast cancer patients, which mostly relied on surveys. A commonly used survey evaluation method is the Pittsburg Sleep Quality Index (PSQI). Using PSQI, one study reported that 66% of the Chinese breast cancer survivors had sleep disorders and 49% had significantly reduced sleep efficiency and time in bed. The group with sleep disorder had lower quality of life, more depression and higher overall stress than the group without sleep disorder. Another survey of breast cancer patients over 69 years old found that pain, fatigue and depression were related to sleep, and that fatigue was the strongest predictor of sleep disorders.

A recent study found that postmenopausal breast cancer patients, starting hormone therapy with aromatase inhibitor, total sleep time and sleep efficiency declined without statistical significance. However, 58% of Korean breast cancer patients are pre-menopausal patients aged 49 or younger, and thus, most patients take tamoxifen and goserelin instead of aromatase inhibitors after surgery. In this reason, results of aromatase inhibitor can not be applied in this population. As previous studies on the effects of tamoxifen on sleep were conducted retrospectively, objective comparisons of before and after applying tamoxifen are difficult and the long-term effects of tamoxifen are difficult to understand.

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed of unilateral breast cancer (stage 0 \~III)
* underwent proper cancer treatment including surgery, chemotherapy, radiation therapy
* age : 18 \~ 45
* scheduled for applying tamoxifen and goserelin

Exclusion Criteria:

* need CPAP device during sleep due to sleep apnea
* under medication for restless leg syndrome
* previous history of tamoxifen
* irregular bedtime due to shift work
* diagnosed of recurrent or metastatic cancer
* have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems
* refuse to participate
* has musculoskeletal system and neurological damage and lesions
Effects of Transfusion of Older Stored Red Cells

The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.

The investigators hope to test:

* whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
* whether washing or cryopreserving the red blood cells has any effect on this outcome.

These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.

Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.

Eligibility Criteria:
Inclusion Criteria (Recipient):

* specific, well-characterized hemoglobinopathy
* chronic simple transfusion therapy (transfusion episodes \< 6 weeks apart in frequency)
* chronic iron chelation therapy
* not pregnant by self-report and not planning pregnancy
* age \> 1 year old

Exclusion Criteria (Recipient):

* clinically unstable
* treatment for mental illness
* imprisonment
* institutionalization

Inclusion Criteria (Donor):

* 21-65 years of age
* male weight \> 130 lbs, female weight \> 150 lbs
* male height \> 5'1", female height \> 5'5"
* hemoglobin \> 15.0 g/dL
* reasonably certain of intention to stay in New York City metropolitan area for study duration
* previously tolerated red blood cell donation

Exclusion Criteria (Donor):

* ineligible for donation based on New York Blood Center blood donor screening questionnaire
* systolic blood pressure \< 90 or \> 180 mm Hg, diastolic blood pressure \< 50 or \> 100 mm Hg
* heart rate \< 50 or \> 100
* temperature \> 99.5 F prior to donation
* positive by standard infectious disease testing performed on blood donors
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.

A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
2. Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive

Exclusion Criteria:

1. Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
2. Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)

The purpose of this study is to characterize the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* non-dialyzed patients with CKD
* indication for Ketosteril according to package insert (PI), including a glomerular filtration rate (GFR) \< 25 mL/min
* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
* adult patients ≥ 18 years

Exclusion Criteria:

* active cancer diseases
* pregnancy or breast feeding
* hypersensitivity to active substances or to any of the excipients in Ketosteril
* hypercalcaemia
* major disorder of amino acid metabolism, e.g., hereditary diseases
* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
* illiteracy or incapability to read or write
Multiple Dose Healthy Volunteer Study of PF-03715455.

Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Healthy volunteer PK study

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Standard healthy volunteer criteria
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.

This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.

Arm I: Radiotherapy. Involved-field irradiation.

Arm II: No further treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:

Abdominal and extra-abdominal fibromatosis (desmoid,

aggressive fibromatosis),

Dermatofibrosarcoma protuberans,

Intramuscular lipoma (infiltrating lipoma),

Diffuse lipomatosis,

Leiomyoma of deep soft tissue,

Diffuse giant cell tumor of tendon sheath (proliferative synovitis).

No clinical evidence of metastases in regional nodes or more distant sites.

No primary intraperitoneal or retroperitoneal tumors.

Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).

No von Recklinghausen's disease.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy: No prior chemotherapy for sarcoma.

Endocrine Therapy: Not specified.

Radiotherapy: No prior radiotherapy for sarcoma.

Surgery: No more than 4 months since definitive surgery for

primary lesion or recurrence.

No prior amputation.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: Not specified.

Hematopoietic: Not specified.

Hepatic: No cirrhosis.

Renal: No evidence of severe renal impairment.

Cardiovascular: No ischemic heart disease.

OTHER:

No prior malignancy except basal cell carcinoma.

No serious infection.

No active bleeding disorder.

No severe concomitant disease.
Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

The purpose of this clinical trial is to determine the effects good or bad of combining BEZ235 along with Everolimus to determine if it is a safe treatment for patients with advanced cancers of different types.

BEZ235 is an agent that was developed to slow down or halt cell growth and proliferation. It works by inhibiting two pathways that are important for cell growth and replication, one is called mTOR and the other is called PI3K.

Everolimus is an agent that also targets mTOR thus also slows down cell growth and spread; in addition, it injures blood vessels that supply cancer cells with nutrition.

The rationale behind combining Everolimus with BEZ235 is to inhibit cell growth and halt cancer spread by greater degree than either drug alone.

BEZ235 is not approved by the FDA for use in humans outside the context of a clinical trial.

Everolimus is FDA approved for the treatment of renal cell carcinoma (kidney cancer), subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), and Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable, and for which standard/curative measures do not exist by RECIST 1.1 measureable lesion which is not declining
* Age ≥ 18 years old at the day of consenting to the study
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate bone marrow and organ function as defined by laboratory values

Exclusion Criteria:

* Previous treatment with PI3K inhibitors
* Concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
* Concurrently using other approved or investigational antineoplastic agent
* Currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, hormonal therapy, etc.)
* Poorly controlled diabetes mellitus (HbA1c \> 8 %)
* Chronic treatment with systemic steroids or another immunosuppressive agent
* Active cardiac disease
* Inadequately controlled hypertension (i.e, SBP \>180 mmHg or DBP \>100mmHg)
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea grade ≥ 2, malabsorption syndrome, or small bowel resection)
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression

This study will compare the antidepressant benefits and cognitive side effects of three different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar depression.

ECT is an important treatment for severely depressed people who do not respond adequately to, or are intolerant of, antidepressant medication. Traditionally, ECT has been administered with one of two standard techniques: bilateral and right unilateral electrode placement. However, these techniques are limited by either low efficacy or high cognitive impairment. Recently, an additional technique for ECT administration has shown promise in preliminary studies: bifrontal ECT. This study will compare this technique to the two traditional ECT techniques in treating people with depressive symptoms.

Participants in this study will be randomly assigned to receive standard bilateral ECT, high-dose right unilateral ECT, or bifrontal ECT in their index course. Depression symptoms, neuropsychological status, and quality of life will be measured throughout the course of the ECT treatment, one week after, and at a 2-month follow-up visit. This study will run for 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unipolar or bipolar depression