cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
* Syndromes of asthma, rhinitis or nasal polyps
* Females who are pregnant or lactating
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
Hot Water Irrigation in Posterior Epistaxis

This study was aimed to assess the efficacy and factors affecting the success of hot water irrigation in management of posterior epistaxis.

Epistaxis has been reported to occur in up to 60% of general population.This condition has incidence peaks at ages younger than 10 years and older than 50 years. Epistaxis appears to occur more in males than females . In rare cases massive nasal bleeding can lead to death.

Nasal bleeding usually responds to first aid measures such as compression.When Epistaxis doesn't respond to simple measures. The source of bleeding should be located and treated appropriately. Treatment options to be considered include topical vasoconstriction, chemical cautery, electrocautery, nasal packing, posterior gauze packing, use of balloon system, and arterial ligation or embolization. Hospital admission should be considered with patients with comorbid conditions or complication of blood loss.

Nasal Hot water irrigation was first described by Guice in 1878 as an effective method of treating severe life-threatening epistaxis. However, the technique was already in use by nineteenth century obstetricians as a method of treating postpartum bleeding . In the second half of the twenties century, nasal packing products and the development of endoscopic sinus surgery almost completely replaced the irrigation technique as treatment for posterior epistaxis. However, Stangerup et al. (1996) have demonstrated that hot water irrigation, using temperatures of up to 50°C, produces vasodilation and oedema of the nasal mucosa without the risk of necrosis and accelerating the clotting cascade.

Hot water irrigation had a higher success rate (55 %) in treating posterior epistaxis, compared with nasal packing (44 %) .Using a modified irrigation technique, was able to stop bleeding permanently in up to 82 %of cases of posterior epistaxis, including patients receiving antiplatelet agents or anticoagulants . During a follow-up period of four to 24 months. Furthermore, successful hot water irrigation was associated with less nasal trauma, significantly less pain, fewer surgical procedures and avoidance of a hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* patients age: \> 10 years.
* Failed first aid measures.

Exclusion Criteria:

* Patients age \< 10 years old.
* Patients with anterior epistaxis.
* Patients presented with hemorrhagic shock.
* Patients presented with post-surgical bleeding.
* Suspected nasal pathology e.g tumors or trauma.
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis

The current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* a self-reported diagnosis of multiple sclerosis
* relapse free in past 30 days
* non-pregnant
* willing and able to visit University of North Texas on two testing occasions

Exclusion Criteria:

* electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)
Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

Aim of the study :

To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD).

Methods :

This is a monocentric retrospective study based on a prospectively maintained clinical database. The study included 28 consecutive patients operated, between January 2016 and March 2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated with the classical open approach by the same surgeon before the first laparoscopic resection at our institution.

The progress achieved over the last 20 years and the growing experience of visceral surgeons in minimally invasive surgery allow us today to embark on increasingly complex surgeries.

Laparoscopic surgery has even become the gold standard approach for many interventions, whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.

However, there are still interventions which, due to their technical difficulty, do not find unanimous consensus among the international scientific community for a possible minimally invasive approach.

The close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic dissection difficult with risk of uncontrollable bleeding.

It seems, however, that the finesse of the dissection and coagulation instruments and the precision of today's optics make it possible to approach the head of the pancreas in completely satisfactory conditions.

Several centers around the world have developed the LPD technique with encouraging results in terms of perioperative mortality without showing any advantage over laparotomy.

At the Montpellier University Hospital we started performing Laparoscopic pancreaticoduodenectomy (LPD) at the beginning of 2016.

The aim of this study is to assess, on the one hand, the morbimortality and the quality of surgery linked to the development of this relatively new technique in a reference center for pancreatic surgery and on the other hand to assess a possible learning curve effect within our experience.

Eligibility Criteria:
Inclusion criteria:

- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria:

-reject the study protocol
Randomized Controlled Trial of Game Changers

The study is a randomized controlled trial (RCT) of Game Changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks.

This RCT of Game Changers, a peer-led group intervention for persons living with HIV (PLWH) in Uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* HIV-positive
* in HIV care at The Infectious DIseases Institute for at least one year

Exclusion Criteria:

* Participated in the prior pilot study of the intervention.
* Has significant cognitive impairment
* Health status is not sufficiently stable to reliably complete 18 month study.
* Does not speak Luganda fluently (index participant); English or Luganda fluently (social network participant)
* spouse/partner or household member are enrolled as index participant in the study
Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients

The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.

All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness \> 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

Exclusion Criteria:

* Heart rate \< 50/min,
* Taking amiodarone
Swedish Ibrance Registries Insights (SIRI)

The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
2. Age ≥18 years at index date

Exclusion Criteria:

There are no exclusion criteria
Registry of Patients With MPNs in Taiwan

Myeloproliferative neoplasms (MPNs) are a group of clonal hematologic malignancies with great variation in reported patient life expectancy and are characterized by a relatively indolent course which can be complicated by thromboembolic events and transformation to acute myeloid leukemia (AML).

The MPNs in the 2016 World Health Organization (WHO) classification of myeloid neoplasms consist of polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) including prefibrotic/early stage and over fibrotic stage, chronic myeloid leukemia, other (rare) disorders such as chronic neutrophilic leukemia and chronic eosinophilic leukemia and MPN unclassifiable (MPN-U).

The prevalence and genetic characteristics of patients with MPNs in Taiwan are still unknown. Molecular tests which are required for the diagnosis of MPNs are not available in many hospitals which hamper the accurate diagnosis and subtype classification of MPNs. Moreover, the information of current therapeutic strategy for MPNs in most medical centers in Taiwan is also not available. The purpose of this MPN registry is to collect clinical data, molecular characteristics, treatment details and response to therapy, occurrence of complications during the course, disease progression to secondary myelofibrosis from PV or ET and secondary AML (sAML) transformation as well as survival. The clinical and molecular data including the high molecular risk (HMR) genes will be examined and correlated with treatment outcomes in Taiwanese MPN patients.

The Molecular Diagnostic Laboratory at Chang Gung Memorial Hospital-Linkou is a College of American Pathologists (CAP)-accredited lab which provides high quality of molecular genetic tests for hematologic malignancies. The three driver gene mutations are the major criteria for the diagnosis of MPN, the methodologies of mutational analyses have been well set up for the clinical use in this lab. In addition, this lab is also equipped with facilities for the detection of mutated genes which were recently identified as HRM category (presence of any of ASXL1, EZH2, SRSF2, IDH1 or IDH2), and mutations of other epigenetic regulators or splicing factors.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥ 20 years.
2. Patient who had a confirmed diagnosis according to the 2016 revised WHO criteria with a Ph (-) MPN.

Exclusion Criteria:

1. Patients do not fulfill the diagnostic criteria of MPN by WHO 2016 classification.
2. Patients unwilling to sign informed consent.
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
* PSA below 20 ng/mL
* Lymph node negative
* Non-metastatic
* Written informed consent

Exclusion Criteria:

* Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
* Distant or nodal metastases
* Prostatectomy
* Concomitant LHRH analog treatment
* Previous or concomitant anti-androgens
* Active ILD
Effects of Buspirone Combined with Clozapine

This study aimed to evaluate the enhancing effects of different doses of buspirone on psychiatric symptoms and cognitive function in patients with schizophrenia. The investigators adopted a prospective, randomised, double-blind, placebo-controlled study design and included 46 patients with schizophrenia being treated at the Fourth People's Hospital of Wuhu. The patients were randomly divided into three groups: the control group, the low-dose group and the high-dose group. The control group received clozapine monotherapy, while the experimental groups received additional buspirone at different doses in addition to clozapine. The Positive and Negative Syndrome Scale (PANSS) and the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status were used to evaluate psychiatric symptoms and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years;
* Meeting the diagnostic criteria for chronic schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Current remission of psychotic symptoms. The patients had a relatively stable mental state in the past 4 weeks, with a total score of ≤60 points and a score of ≤4 points on the Positive and Negative Syndrome Scale (PANSS)\[15\], and there were no signs of acute psychotic symptoms. To ensure that patients were included in the chronic phase, only patients who had been diagnosed with schizophrenia for ≥1 year were recruited, thus avoiding confusion with acute phase cases;
* Receiving monotherapy with antipsychotic drugs, such as clozapine.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients allergic to buspirone;
* Patients previously diagnosed with cognitive impairment, such as dementia or intellectual disability;
* Patients with a history of other brain injuries or diseases, such as stroke, traumatic brain injury, epilepsy or intracranial infection;
* Patients with severe liver or kidney insufficiency;
* Patients with severe physical diseases or other mental illnesses, such as bipolar disorder, major depressive disorder, alcohol or substance dependence;
* Patients with a history of using drugs that affect cognitive function during the study period or those who need to adjust the existing treatment regimen;
* Patients who are unable to cooperate with cognitive function tests or have poor treatment compliance.
HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS

Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.


Eligibility Criteria:
Inclusion Criteria:

* Participants in the FHS Offspring who answered questions in the FFQ about soft drinks, fruit drinks and fruit juice consumption; Participants with non-missing data for the exposures and potentially confounding variables of interest.

Exclusion Criteria:

* Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)
Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

PURPOSE: The main purpose is to explore clinical efficacy and safety associated with capsule FMT (cFMT) performed in newly diagnosed, untreated patients with rheumatic and gastrointestinal chronic inflammatory diseases (CIDs).

DESIGN AND METHODS: In this 1:1 double-blind, placebo-controlled, randomised, 12-month exploratory trial, 200 patients with at least one of 6 different diagnoses of CIDs fulfilling the study criteria will be enrolled at time of diagnosis. The patient groups are: rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), pulmonary sarcoidosis (PSar), Crohn's disease (CD), and ulcerative colitis (UC). The primary endpoint is change from baseline to eight weeks in the physical component summary (PCS) of the short form health survey (SF-36). Key secondary clinical endpoints will be evaluated at 8 weeks. Other secondary clinical endpoints will be evaluated at 52 weeks and reported in secondary papers.

The baseline visit will be performed as quickly as possible after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by CID diagnosis, patients will be randomised (1:1) to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors. The experimental intervention FMT/placebo will be repeated once weekly the first month (i.e., each patient will receive a total of four treatments). In addition, all participants will concomitantly be offered the national guideline first-line anti-inflammatory treatment following the baseline visit.

At baseline, 8 weeks, 26 weeks, and 52 weeks a thorough clinical examination will be conducted and all relevant clinical scores for each disease entity will be registered. Patient-reported-outcomes including SF-36 and disease specific questionnaires will be collected at week 1, 2, 3, 4, 8 (primary endpoint evaluation), 26 and 52. Adverse events will be monitored through out the trial.


Eligibility Criteria:
Inclusion criteria:

* Newly diagnosis of treatment-naïve RA, AS, PsA, PSar, CD, or UC.
* Treatment-naïve which is defined as no current or previous (within 3 months) disease-modifying anti-rheumatic drugs (DMARDs) or systemic anti-inflammatory treatment including glucocorticoids.
* Presence of CID treatment indication (no contra-indications) and patient accept to start first-line standard treatment in accordance with the national guideline for the specific diagnosis following the baseline visit.
* Age 18 to 75 years.

Exclusion criteria:

* Indication for biological therapy as primary therapy.
* Celiac disease or food allergy.
* Current cancer.
* Hepatitis B and C, HIV, HTLV1/2, and active TB or other serious chronic infections.
* Pregnant or breastfeeding women.
* Not wishing to participate or not suited for FMT intervention or project evaluation.
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years
* Eastern Cooperative Oncology Group Performance Status is 0 -2
* Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
* The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
* Invasive adenocarcinoma of the breast on histological examination
* The metastatic site must be identified by radiological assessment(Computer Tomography of the chest and the abdomen OR ultrasound and chest x ray for visceral metastases; bone scan AND/OR computer tomography AND/OR magnetic resonance for bone metastases). A biopsy is not necessary.
* Written informed consent must be obtained and documented prior to beginning any protocol specific procedures and according to local regulatory requirements
* able to comply with the protocol requirements during the treatment and follow-up period.

Exclusion Criteria:

* Patients in whom a R0 resection (microscopic free margins) is clinically questionable
* Inflammatory cancer
* Patients with a brain metastasis
* Patients who are not eligible for general anesthesia and operations
* Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)
* Patients with a second untreated malignancy
* Any previous malignancy treated with curative intent and the patient has not been disease-free for 5 years - exceptions are: (a)carcinoma in situ of the cervix, (b)squamous carcinoma of the skin, (c)basal cell carcinoma of the skin
* Patients with any recurrent cancer disease
* Pregnant or lactating women
* Patients are not allowed to be part of another local therapy trial