cyrilzakka/clinical-trials huggingface dataset:
Reducing Hazardous Alcohol Use and Optimizing Treatment As Prevention Among Men Living with HIV in Risk Environments

The investigators developed the Kisoboka ("It is possible") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in "risk environments" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads.

Social and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing "reward" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a "live for today" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity.

The goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention.

Participants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.


Eligibility Criteria:
Inclusion Criteria:

1. living with HIV;
2. residing in a fishing community (on most days/nights);
3. AUDIT-C positive (≥4) indicating potential hazardous drinking;
4. \>6 months since initial antiretroviral treatment (ART) initiation;
5. an indicator of potential suboptimal treatment as prevention (TasP) either:

(i) last HIV viral load test (within 6 months) was detectable (\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks; (f) not planning to move from the area within the next 6 months; (g) have their own mobile phone and can be reached via phone.

Exclusion Criteria:

1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
2. does not speak Luganda or English;
3. currently receiving a majority of work payments via mobile money/digital payments;
4. participated in the Kisoboka pilot RCT;
5. unable to read basic Luganda or English
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers

The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* Right handed
* 12th grade education or equivalent
* Able to read and write English as primary language

Exclusion Criteria:

* History of head injury
* Substance abuse or dependence
* History of claustrophobia
PTC299 for Treatment of Neurofibromatosis Type 2

Formation of new blood vessels (angiogenesis) is important for tumor growth in neurofibromatosis type 2 (NF2). It is known that tumors make a protein called vascular endothelial growth factor (VEGF) and there are higher levels of VEGF in the tumors and blood of many patients with NF2. VEGF stimulates the formation of blood vessels that supply the tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease production of VEGF in animal models of human cancer. In these animal models, oral PTC299 administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in research animals indicate good tolerability at doses and drug levels that are higher than those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active in animal models of human tumor. This Phase 2 study is designed to test the hypothesis that PTC299 will be tolerable and will show evidence of VEGF reduction, antitumor activity, and hearing improvement when administered orally to patients with NF2.

The study will be conducted in 2 stages. In Stage 1 of the study, 11 patients will receive daily treatment with PTC299 administered at 100 mg/dose twice per day for up to 1 year or until tumor progression. If no subject responds with tumor shrinkage or an improvement in hearing, then the study will be stopped. If ≥1 out of 11 subjects respond, then the study will proceed to Stage 2 to enroll an additional 14 subjects for a total of 25 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of NF2
* Presence of vestibular schwannomas
* Evidence of progressive increase in vestibular schwannoma size or worsening hearing loss due to vestibular schwannoma
* Adequate functional status (Karnofsky Performance Score ≥60)
* Adequate bone marrow, liver, kidney function
* If sexually active, willingness to use effective barrier or medical contraception
* For women of childbearing potential, no pregnancy or breast-feeding
* Discontinuation of other therapies (except corticosteroids) for the treatment of NF2 and resolution of any acute toxic effects of prior therapies
* Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
* Willingness to provide informed consent

Exclusion Criteria:

* Uncontrolled hypertension, major bleeding, HIV infection, or recent acute cardiovascular event
* Prior exposure to another anti-angiogenic therapy (eg, bevacizumab, sunitinib)
CESM ABMR Breast Cancer Screening Trial

This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.

Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).

Secondary Aims:

1. Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
* Women aged ≥18 years at the time of enrollment
* Referred clinically for breast MRI for any indication

Exclusion Criteria:

* Known allergy or contraindication to iodinated contrast
* Are currently pregnant based on urine pregnancy test
* Have breast implants
* Are lactating
NC Young Women's CoOp

This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.

The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.

Eligibility Criteria:
Selected Inclusion Criteria:

* Identify as female
* Identify as Black or African American
* 18-25 years of age
* Have used alcohol or drugs in greater quantity or for a longer period of time than intended within the past 30 days

Exclusion Criteria:

* Participants may not be non-Black/African American
Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging

In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.

Radiomics features provide complementary information about tumor heterogenity.

The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced rectal cancer
* patients who received concomitant radio-chemotherapy followed by surgery
* pre-therapeutic MRI and CT-scan dicom available

Exclusion Criteria:

* age under 18 yo
* lack of MRI or CT-scan
Study of Auditory Perception After Progressive Exposure to Aversive Sounds in People With Misophonia

The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.


Eligibility Criteria:
Inclusion Criteria:

For all participants

* Obtain oral consent from the participant after receiving information about the study,
* Be 18 years or older on the day of inclusion,
* Be fluent in French (spoken and written),
* Have no known hearing loss, verified by pure tone audiometry.
* Declare that they do not have tinnitus,
* Declare that they do not have hyperacusis, verified by measuring discomfort thresholds.
* Be affiliated to the social security or equivalent scheme.

For participants with misophonia:

- Declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.).

Exclusion Criteria:

* Bear the after-effects of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
* Be under guardianship,
* deprived of liberty by judicial or administrative decision, or subject to legal protection.
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)

Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.


Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Patients who tested positive for hepatitis B surface antigen (HBsAg) for \>6 months
* Meet the criteria of anemia
* Ages Eligible for Study: ≤75 years old;
* Informed consent from the patient.

Exclusion Criteria:

* Patients with upper gastrointestinal bleeding within 3 months before enrollment;
* History of blood transfusion within 3 months before enrollment;
* Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug.
Online Self-help for Depressed Patients Awaiting Psychotherapy

Patients with major depression who are on a waiting list for psychotherapy usually suffer from considerable symptoms. Online self-help is one potential way to alleviate this suffering. The investigators want to study if patients awaiting psychotherapy benefit from online-self help. The investigators therefore randomly assign patients to either online self-help or no intervention and assess their depressive symptoms on a regular basis. The investigators hypothesize that online self-help will be superior to no intervention in alleviating depressive symptoms in depressed patients awaiting psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* stable medication
* 18yrs. or older

Exclusion Criteria:

* current psychotherapy
* acute suicidality
* unavailability of internet connection
A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.


Eligibility Criteria:
Inclusion Criteria:

Study will enroll adult patients (age \>18 years) with hypertensive paroxysms during the past 6 months (preferably during the past 6 weeks) - abrupt elevations of systolic blood pressure (BP) ≥20% compared to previous measured systolic BP value before paroxysm, or ≥20% compared to mean systolic BP on 24-hour ambulatory blood pressure monitoring (ABPM), or ≥20% compared to measured office systolic BP, documented by a clinician or home blood pressure monitor, requiring physician or emergency room visit or the use of any rescue antihypertensive medication. Hypertensive paroxysms may be accompanied by abrupt onset of one or more distressful physical symptoms, such as headache, chest pain, dizziness, nausea, palpitations, flushing, and diaphoresis.

Exclusion Criteria:

Pregnancy or breastfeeding, hypersensitivity to sertraline (Zoloft®) or of the the components of this drug. Current use of sertraline or any other selective serotonin reuptake inhibitor (SSRI), mono-amin oxidase (MAO) inhibitors, selegiline, moclobemide, linezolide, pimozide. Current use of other serotoninergic drugs (eg. tryptofane, triptane and other 5-HT agonists), tramadol or dopamine antagonists (including antipsychotics).
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital

The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data.

Tuberculosis (TB) is a problem of global importance, it is a medical, social and economic disaster of immense magnitude that is occurring over the world

TB remains one of the major health risks associated with morbidity and mortality. Worldwide, about 10 million TB cases have been reported in 2017, and about 1.57 million cases have died The estimated global average risk of infection is 1%, implying approximately 38 million new infections per year among the previously uninfected population .

In Egypt ,researchers have found evidences of tuberculosis in the Egyptian mummies dating from 3000 to 2400 Before Christ and WHO reported that TB is the most important public health problem after hepatitis C , TB disease can affect any organ, but most commonly occurs in the lungs (70%-80%). Pulmonary TB is the most important form of TB infection, because an infection of the lungs is highly contagious due to the mode of droplet transmission .

Patients with TB usually manifest diverse signs and symptoms that vary with age, sex and the associated socio-environmental as well as host factors .

Eligibility Criteria:
Inclusion Criteria:

* All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.

Exclusion Criteria:

* Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.
68Ga-DOTA-TATE PET/CT Imaging in NETs

This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).


Eligibility Criteria:
Inclusion Criteria:

1. Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
2. Patients with suspected or proven tumors expressing somatostatin receptors
3. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion Criteria:

1. \*Pregnancy (not an absolute exclusion). See below\*.
2. Patient refusal to participate.
3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.

   * In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:

     * Severe medical condition involving the life of the pregnant woman and/or the fetus;
     * Existing treatments that are ineffective or may present toxicity to the woman and/or fetus;
     * High clinical suspicion of a somatostatin receptor overexpressing tumour;
     * Negative, indeterminate or contraindicated first-line imaging tests;
     * Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery;
     * Documented discussion with the treating team and the patient;
     * Patient agrees.
Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C

The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.

In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.

The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Anti-HCV positive for \> 6 months
* Genotype 1
* Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
* Negative pregnancy test (for fertile women)

Exclusion Criteria:

* Pregnancy or breast-feeding
* Antiviral or immune modulating treatment the last 6 months
* Hepatitis B or HIV infection (HBsAg, anti-HIV)
* Other significant chronic liver disease
* History of bleeding esophageal varices or other signs of decompensation
* Neutrophiles \< 1.0 x 109/L or platelets \< 50 x 109/L. S-creatinine \> 2 x ULN
* History of severe psychiatric disorder
* Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
* Drug abuse, current or during the last year