cyrilzakka/clinical-trials huggingface dataset:
Impart: Provider-Assisted HIV Partner Notification

Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index patients recruited from two all-male prisons in Indonesia to assess the acceptability and feasibility of provider-assisted HIV partner notification (provider referral) and examine its potential to increase the number of partners who are tested for HIV and subsequently linked to prevention and treatment services.

This study compares three options for partner notification:

* Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his partner(s) and given information about sites where his partner(s) can receive free HIV testing.
* Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a counselor (project staff) present. Counselor refers the partner to HIV testing, including a study-affiliated HIV testing site.
* Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). Partners are offered immediate HIV testing in their home or at a study-affiliated HIV testing site.

Eligibility Criteria:
Inclusion Criteria for HIV-positive Prisoners (N=65): Index patients must beat least 18 years of age, HIV-seropositive and aware of their HIV+ status; (HIV-infection documented by a rapid HIV test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. We will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified.

Inclusion Criteria for Partners: Eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. No named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.
Compare the Effect of DPP-IV Inhibitor or TZD on Glycemic Variability and Oxidative Stress in Patient With 2 Diabetes

The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.

Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with age 18-80 years
* Type 2 diabetes mellitus
* On stable dose of metformin (more than 1000mg) for at least 1 month
* HbA1c 7\~10%
* Subjects on statins, ACE inhibitors, ARBs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study
* BP under control - no change required to BP medications
* Agreement to maintain prior diet \& exercise

Exclusion Criteria:

* Type 1 DM or Any kind of secondary DM
* Pregnant or lactating women.
* Treatment with sulfonylurea, α-glucosidase inhibitor, glinide, GLP-1 analogues, DPP-IV inhibitors or insulin therapy within 1 month prior to informed consent.
* Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent.
* HbA1c \<7% or \>10%
* Uncontrolled hypertension ( BP \> 160/100 mmHg)
* Congestive heart failure (NYHA class I to IV).
A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.

This study is seeking for participants who are:

* between the ages of 18 to 49 years old or 65 to 84 years old.
* willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures.
* healthy as confirmed by medical history, physical examinations, and the study doctor.
* capable of signing informed consent.

Participants will receive either:

* the pdmFlu vaccine,
* a licensed influenza vaccine
* a placebo. A placebo does not have any medicine in it but looks just like the study medicine.

Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.


Eligibility Criteria:
Key Inclusion Criteria:

- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Key Exclusion Criteria:

- Does not meet seasonal influenza vaccine requirements per cohort.
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes

Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.

The multi-modal pain therapy includes:

* specific drug therapy
* pain education
* psychological therapy
* physical therapy
* behavioral therapy
* work hardening
* bio-feedback
* ergotherapy

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years and \<= 65 years
* verified chronic pain for more than 6 month

Exclusion Criteria:

* application for a pension
* non-accordance with multi-modal pain therapy
* dominant geriatric symptoms
* dominant psychiatric symptoms
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.


Eligibility Criteria:
Inclusion criteria

1. Males and females aged 18-65 years inclusive.
2. First time recipients of cadaveric, living unrelated or living related donor kidney transplants.
3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

1. Patients who are recipients of multiple organ transplants, including more than one kidney, kidney and pancreas, or previous transplant with any organ other than kidney.
2. Patients at high immunological risk of graft loss, indicated by peak PRA \>50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.
3. Patients who have received an investigational drug within 4 weeks prior to the screening visit.
4. Presence of any severe allergy or hypersensitivity to drugs similar to everolimus (e.g. antibiotics such as Clindamycin)

Other protocol-defined inclusion/exclusion criteria may applied
Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).

The main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye.

Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).

Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma treatment will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
* Patients ≥ 18 years at the screening visit.
* Ocular hypertension or glaucoma controlled with hypotensive treatment
* Diagnosis of dry eye

Exclusion Criteria:

* Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
* Changes in topical glaucoma treatment in the last 3 months
* Severe dry eye requiring immediate treatment
* Previous eye surgery, except cataract surgery more than 12 months ago
* Laser procedures less than 6 months ago
* Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
* Eyelid disorders
* Use of contact lenses
* Other topical treatment other than dry eye and glaucoma
* Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
* Modifications in systemic immunosuppressive treatment in the last 6 months
* History of alcohol or drug abuse
* Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
* Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
* Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.
Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents

Study about the improvement of cognitive, psychopathological and functional abilities in Hepatitis C Virus (HCV) infected patients after eradication of the virus with direct antiviral agents.

The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables.

The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption.

A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE).

The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with indication to receive antiviral treatment
* Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection

Exclusion Criteria:

* Active alcohol consumption\> 40g daily or history of chronic alcoholism
* Active consumption of other toxics (heroin, cocaine, cannabis)
* Patients with minimum hepatic encephalopathy
* Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions.
* Active use of psychotropics or benzodiazepines
Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV

The goal of this clinical trial is to conduct a dietary intervention targeting HIV specific gut microbiota alterations for primary atherosclerotic cardiovascular disease (ASCVD) prevention and evaluate its effectiveness in preventing ASCVD among people living with HIV (PLWH).

Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months.

The investigators utilize a pragmatic randomized controlled trial design to evaluate the effectiveness of dietary intervention in real-world conditions, without strict control, thereby enhancing the generalizability and clinical applicability of our study findings. Participants at Shenzhen Third People's Hospital, exhibiting HIV with a borderline or medium risk of atherosclerotic cardiovascular disease (5% to \<20%) determined by the pooled cohort equation, will be enrolled. Upon providing informed consent, participants will undergo dynamic randomization into intervention and control groups, aiming for a 1:1 ratio while preserving maximum unpredictability. The intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months. Primary outcomes will assess ASCVD risk via the pooled cohort equation and evaluate gut microbiota diversity and composition. Secondary outcomes will encompass biomarkers and predictors associated with atherosclerotic cardiovascular disease, as well as symptoms related to the condition.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
2. Aged 18 years and above;
3. PCE predicted ASCVD risk of 5% - \<20%;
4. Those with a predicted survival time of \>1 year;
5. No plans to leave the depth in the next 3 months;
6. Voluntary participation in this study and signing the informed consent.

Exclusion Criteria:

1. Those with a previous history of CVD;
2. Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;
3. Currently suffering from malignant tumors, kidney diseases, gastrointestinal diseases; People with an aversion to eating;
4. Allergic to nuts and fish;
5. People who take medicinal calcium \>1000 mg per day or omega-3 supplements;
6. Plan to become pregnant within 6 months;
7. Are participating in other HIV-related or dietary intervention-related scientific research programs.
Randomized Controlled Trial of Integrated Early Palliative Care

This study verifies whether integrated Early Palliative Care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis.

Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety.

This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival.

Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject 20 years and older.
* Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor
* Subject whose ECOG performance status is between 0 to 2.
* Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist)
* Subject who volunteers

Exclusion Criteria:

* Inability to speak, understand or write Korean.
* Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea)
* Suspension of all cancer treatment
* Palliative care consultation at any time or in palliative care
Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers

This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.

A more detailed description is not desired as noted above.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 -60
* BMI between 20 -38
* Willing to attend 10 weekly education sessions
* Able to speak and understand Spanish
* Have medical insurance

Exclusion Criteria:

* Fasting blood glucose about 126mg/dL unless physician attests fit to participate
* Pregnancy or trying to conceive, or breastfeeding
* Diabetic
* On therapeutic diets
* On medications that affect weight
* If spouse / cohabitant already in the study
* Not a farm worker working for the Reiter Affiliated Companies
Socio-economic Status and Age-related Disability in a Biracial Community

The overall goal of the proposed project is to examine the reasons for the higher levels of disability in older people of lower socio-economic status.

This application is a continuation of an epidemiologic study that investigates the effect of socio-economic disadvantage and neighborhood conditions on disability in older blacks and whites. The proposed project takes place in the context of a population-based, longitudinal study of persons aged 65 years and over who live in a geographically defined, urban, biracial community area in Chicago. During the initial funding period, we have successfully collected yearly disability outcome data, and detailed information on neighborhood conditions using self-report instruments and a systematic neighborhood survey of study area.

The first overall goal of this continuation is to determine the relative contribution and specific nature of the neighborhood conditions that are associated with disability in older adults. The second overall goal is to determine the biological mechanisms through which neighborhood conditions lead to increased disability, focusing specifically on hyperactivity of the hypothalamus-pituitary-adrenal (HPA) axis, via salivary cortisol, and inflammatory processes, via interleukin-6 (IL-6) and C-reactive protein (CRP), obtained from blood samples. To accomplish these goals, we propose to continue yearly collection of disability outcome data and obtain blood samples and salivary cortisol from over 7,000 participants. These data will be integrated with a rich set of existing data on personal characteristics, health conditions, and neighborhood factors to test of series of specific hypotheses related to the overall goals.

Disability is a common and highly prevalent consequence of age-related chronic diseases, and a critical indicator of overall health among older people. Prevention of disability is essential to improve the lives of older people and reduce health care costs. The proposed work will contribute to a better understanding of the specific neighborhood conditions that are associated with increased disability, laying the foundation for more effective policies to prevent disability in future generations of older adults.

Eligibility Criteria:
inclusion criteria: adults aged 65 years and over exclusion criteria: none