cyrilzakka/clinical-trials huggingface dataset:
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of endogenous anterior uveitis or panuveitis
* Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
* Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
* Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
* Patients giving written informed consent prior to initiation of the study

Exclusion Criteria:

* Patients who did not meet all of the above inclusion criteria
* Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
* Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
* Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
* Patients with glaucoma or ocular hypertension
* Patients with corneal erosion or corneal ulcer
* Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
* Patients with allergy to similar drugs of difluprednate
* Patients requiring use of contact lens during the study period
* Women who were or might be pregnant, or lactating women
* Patients participating in another clinical study within 3 months before initiation of the present study
Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia

Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.

This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years).

Patients will be randomly divided into the following two treatment groups: 1. Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. 2. Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.

The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. The patient will be transferred to the other group if intolerance or resistance occurs.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old.
* Male or Female.
* Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
* Those who have not use interferon within 4 weeks before the first medication.
* Patients with indications for cytoreductive therapy.
* Men and women with reproductive potential, as well as all women with menopause less than 2 years, must agree to use acceptable contraceptive methods until 28 days after the last dose of study drug, and women must agree not to breastfeed during the study period.
* Voluntary written informed consent.

Exclusion Criteria:

* Resistance, or intolerance, or any contraindications to interferon.
* Patients with active thrombosis or active bleeding.
* Neutrophil count \< 1.0x10\^9/L.
* Hemoglobin \< 11g/dL for male, or \< 10g/dL for female.
* Poor control of thyroid dysfunction.
* Patients with a prior malignancy within the last 3 years.
* Patients with severe cardiac or pulmonary dysfunction.
* Severe renal damage (creatinine clearance \< 30 ml / min).
* Severe liver dysfunction (ALT or AST \> 2.5×ULN).
* Patients with hepatitis B virus, hepatitis C virus replication or HIV infection.
* Patients with a history of drug / alcohol abuse (within 2 years before the study).
* Patients that have participated in other experimental researches within one month before enrollment.
* History of psychiatric disorder.
* Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
Beta Glucan and Acetate Production

Based on our hypothesis that orally administered resistant starch and beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:

To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.


Eligibility Criteria:
Inclusion Criteria:

* lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
* normoglycemic
* aged 30 - 65 years

OR

* overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
* pre-diabetes
* aged between 30 - 65 years.

Exclusion Criteria:

* diabetes mellitus
* gastroenterological diseases or major abdominal surgery (allowed i.e.: ---appendectomy, cholecystectomy)
* lactose intolerance and other digestive disorders
* cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
* disease with a life expectancy shorter than 5 years
* Use of antibiotics 3 months prior inclusion
* Use of probiotics or prebiotics
Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C

The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and non-selective immunological disturbance that leads to necro-inflammation and progression of fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional supplement with hepatoprotective properties, could ameliorate the oxidative stress and modulate the immune response in patients with CHC and non-responders to pegylated interferon plus ribavirin, during 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
* Histological diagnosis of chronic hepatitis.
* Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment.
* Age between 18 and 65 years.
* Ability to provide informed consent.
* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria:

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency).
* Pregnancy or lactation.
* Decompensated cirrhosis.
* Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
* Refusal to participate in the study.
* Concomitant disease with reduced life expectancy.
* Severe psychiatric conditions.
* Drug dependence.
* Co-infection with hepatitis A or B or HIV.
* Pregnancy.
A Working Memory Training in Burnout Patients

Burnout patients show deficient working memory functioning. Several studies showed a training can increase working memory capacity. In the current study we explored whether training working memory can reduce burnout and burnout related symptoms and increase working memory capacity.


Eligibility Criteria:
Inclusion Criteria:

* undifferentiated somatoform disorder with a work related cause

Exclusion Criteria:

* age which exceeded the range of 18 to 67 years
* a severe major depressive episode
* substance dependence or abuse
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity.

Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T):

1. To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
2. To generate comprehensive multiomic profile analysis following CAR-T therapy.
3. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be in the process of undergoing cancer cell therapy at Stanford University.

  * Adults \> 18 years
  * Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.)
  * English speaking
  * Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection

Exclusion Criteria:

* In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia

Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability to those who suffer it. Currently, other treatment resources are being implemented, such as aquatic therapy. This therapy seems to provide positive results in different dimensions of fibromyalgia.

The main objective of the study is to determine the effectiveness of a physical therapy program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction and improvement balance at the end of treatment and a month and a half later (follow-up).

The type of study is a randomized controlled opened trial. The sample is composed of 34 women with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2 groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be assessed using a electronic algometer. Static balance will be evaluated with the Romberg's test and the dynamic balance with the Timed Up \& Go test (TUG) and Berg Balance Scale. Both type of balance will be recorded in slow motion and then, will be analysed with a motion software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR); the sleep quality, that will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI); the fatigue, that will be evaluated witn the "Multidimensional Fatigue Inventory" (MFI); the physical capacity, that will be measured with the "six minute walk test" (SMWT) and confidence in balance that will be assessed with the "Activities-specific Balance Confidence" scale (ABC).

Each intervention will last one hour and will be made 3 times a week for three months . It will consist of 4 sections: Warming, exercises for static and dynamic balance training, stretching and relaxation. Statistical analysis will be made using the Statistical Package for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance level set for all analysis.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Age range between 35 and 64 years.
* Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and 2010.
* Mark ≥ 4 on the Visual Analogue Scale (VAS).
* Mark ≥ 5 on the Visual Analogue Scale for balance included in The Revised Fibromyalgia Impact Questionnaire (FIQR).

Exclusion Criteria:

* History of severe trauma.
* Neurological diseases (stroke, Parkinson's disease, dementia).
* Frequent migraines.
* Inflammatory rheumatic diseases.
* People who have been treated in the past six months by traumatic injuries.
* Being pregnant.
* Visual or hearing deficits uncorrected.
* Infectious diseases.
* Severe cardiovascular disease.
* People who do exercise regularly more than 20 minutes, more than 3 times a week in the past 3 months.
Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU

The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.

This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:

1. What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
2. What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
3. Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?

Eligibility Criteria:
Index participant

Inclusion Criteria:

* laboratory confirmed HIV positive diagnosis
* able and wiling to bring an injecting network member for screening
* injected drugs in previous 6 months
* planned residence in Thai Nguyen for next 24 months

Exclusion Criteria:

* unwilling to provide locator information
* unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
* currently participating in other HIV or drug use intervention activities

Network member participant

Inclusion Criteria:

* laboratory confirmed HIV negative diagnosis
* injected or shared drug paraphernalia in past 6 months
* interacts at least once a week with index participant

Exclusion Criteria:

* unwilling to provide locator information
* having psychological or cognitive impairment
* currently participating in other HIV intervention
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA \<0.70 ng/ml) after prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 10 years
* Age ≥18 years.
* World Health Organization (WHO) performance status 0-1.
* Estimated life expectancy \>10 years.
* Histological evidence of prostate cancer in the prostatectomy specimen
* Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0.
* Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA \<0.70 ng/ml.
* Patients must be able to comply with the protocol.
* Signed informed consent.
* Adequate laboratory findings (Haemoglobin (Hb) \>90g/L, absolute neutrophil count \>1.0x109/L, platelets \>75x109/l, bilirubin \<1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) \<5x ULN and creatinine \<1.5 ULN).

Exclusion Criteria:

* Metastases (regional lymph nodes or distant)\* diagnosed with imaging.
* Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).
* Prior radiotherapy to the pelvis.
* Prior malignancy other than prostate cancer and basalioma in the past five years.
* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure.
* Severe pulmonary disease.
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients

The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.

The main questions it aims to answer are:

* Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients?
* How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population?

Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term.

Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B).

In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription.

In all patients, quality of life, gut microbiota, inflammatory and cardiovascular biomarkers (Framingham score, BNP, etc.), lipid profile and renal function over time will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
* Minimum age, 30 years;
* Maximum age, 69 years;
* Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
* Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
* Obtaining informed consent;

Exclusion Criteria:

* Patients unable to follow the prescription,
* Recent acute cardiovascular event (\< 2 months),
* Unstable angina,
* Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
* Severe aortic stenosis,
* Heart failure NYHA class III-IV, FE \< 40%,
* Acute illnesses that limit physical activity,
* Severe hypertension (basal BP ≥200/110 mm Hg),
* Neuro-musculo-skeletal pathologies that may be aggravated by exercise,
* Patients unwilling to change lifestyle;
* Any form of substance abuse, psychiatric disorder or condition that, according to the investigator, can complicate communication between doctor and patient;
* Pregnant women.
Viral and Antiretroviral Dynamics in HIV-1 Mother-to-Child Transmission Fluids

More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is possible because HIV drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of delivery and during the breastfeeding period. However, some women do not start taking these drugs on time because they become infected during pregnancy or lactation. This leads to detectable virus at the time of delivery and puts the baby at risk of becoming infected. Also, the amounts of HIV drugs in the body have to be at certain levels for them to work effectively. But findings from some research have recently showed that pregnancy increases the rate at which the body removes some HIV drugs used to prevent the transfer of HIV from mother to child. While this may not cause any problem in women with no detectable virus before pregnancy, it may affect the rate at which the HIV virus is removed from the body in those starting treatment late and may put the baby at risk. This project will investigate whether the changes in drug exposure caused by pregnancy or other factors have any effect on the rate at which the HIV virus is removed from the body. HIV positive pregnant women and those who recently delivered will be recruited from different hospitals and follow up will be until breastfeeding ends. The investigators will not be involved in treatment decisions and the primary care provider will be responsible for prescribing antiretroviral regimen based on current guidelines. Samples will be collected to measure levels of the virus and the drugs in three fluids that transfer the virus to the baby: blood, genital fluid, and breastmilk. The HIV status of the babies will be monitored until they stop breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Planned exclusive breastfeeding until 6 months of age
* Able to understand study information and comply with follow-up schedule

Exclusion Criteria:

* Severe maternal or infant illness
* Planned exclusive formula feeding
* Taking medication with known or uncertain interaction with study drugs