cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) \<40 copies/mL at Week 48.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive
* Naïve to antiretroviral therapy including investigational antiretroviral agents
* Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study

Exclusion Criteria:

* Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence
* Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine
* Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir before the first dose of study drug
* Has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study
* Has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed)
* Requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of Magnesia™
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs
* Has current, active diagnosis of acute hepatitis due to any cause
* Is pregnant, breastfeeding, or expecting to conceive during the study
* Female participant expecting to donate eggs or male participant expecting to donate sperm during the study
* Is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial
SV2 PET Imaging with [11C]APP311

The aim of this study is to evaluate a new SV2A tracer, \[11C\]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give voluntary written informed consent
* Male and Female subjects, age 18 to 65 years, inclusive

Exclusion Criteria:

* MRI metal exclusions and claustrophobia.
* Education completed is less than 12 years
Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer

Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
* At least 18 years of age at the time of consent.
* The subject is clinically node negative (cN0) at the time of screening.
* In Melanoma Patients

  * Diagnosis of primary melanoma with sentinel node indication ( \>0.8 mm Breslow thickness; clinically negative lymph nodes)
* In Breast Cancer Patients

  * T1-T2 N0 breast cancer.
  * Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
* In Oral cavity tumors patients

  * T1-T2 N0 oral cavity squamous cell carcinoma

Exclusion Criteria:

* Pregnancy or lactation
* Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
* Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
* Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
* Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs

This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.


Eligibility Criteria:
Inclusion Criteria All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion.

Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center.

Exclusion Criteria Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center.

Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.
G-CSF in the Treatment of Toxic Epidermal Necrolysis

NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.

Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission

Exclusion Criteria:

* Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
* Hypercoagulable state
* Cardiac or peripheral arterial disease
* Active malignancy
* Myelodysplastic syndrome or hematological malignancy
* Fructose intolerance
* Pregnancy
* Patient refusal
Indocyanine Green Test in Bariatric Surgery

Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time


Eligibility Criteria:
Inclusion Criteria:

* BMI\>40kg/m2

Exclusion Criteria:

* Non obese patients
Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer

Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age.
* The patient has histologically or cytologically confirmed, non-resectable, Stage II-IV primary adenocarcinoma of the pancreas.
* The patient has had a baseline computed tomography (CT) scan, or magnetic resonance imaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.
* The patient has never been treated with prior chemotherapy, with the exception of low-dose 5-fluorouracil (5-FU) as a radiation sensitizer.
* The patient has sufficiently recovered from the effects of previous surgery (no less than 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no less than 4 weeks prior to randomization).
* The patient's estimated life expectancy is at least 12 weeks.
* The patient has a Karnofsky Performance Status between 50 and 100.
* The patient has adequate bone marrow function.
* The patient has adequate hepatic and renal function.

Exclusion Criteria:

* The patient has any active, uncontrolled infection requiring antibiotics.
* The patient has any serious, uncontrolled concomitant systemic disorder.
* The patient has surgery scheduled within 8 weeks following initiation of treatment.
* The patient is pregnant or nursing.
* The patient is not capable of consistent oral intake of at least 3 L/day of fluid and/or requires constant intravenous (IV) hydration or frequent tube feeding.
* The patient is receiving any investigational agent(s) or has been a participant in a clinical trial within the last 30 days.
Molecular Subtyping of Triple-negative Breast Cancer and African Ancestry-related Immunogenicity

Triple-negative breast cancer (TNBC) is a heterogeneous disease that is associated with a younger age of onset, worse stage matched-outcomes, and women of African ancestry in North America. A higher incidence of TNBC is also seen in West Africa, despite unique environmental, socioeconomic and modifiable risk factors. Transcriptome analysis of TNBC has delineated four distinct subgroups with therapeutic and prognostic significance. With further characterization, important regional differences have emerged between populations of African vs. European ancestry. These differences may have significant implications for the efficacy of novel TNBC-targeted therapy and need to be further evaluated. Transcriptional data on TNBC in sub-Saharan African also offers the opportunity to evaluate the relationship between breast cancer phenotype and ancestry-linked differences in the tumor-immune microenvironment.

This study seeks to characterize the mRNA profile of TNBC in Nigeria and compare to a reference population in Nova Scotia. Insight into the unique tumor-immune profile of TNBC in Nigeria and the link between the West African-linked Duffy-antigen receptor for chemokines (DARC) and TNBC subtype will be explored for the first time.

Fresh frozen TNBC tissue from the African Research Group for Oncology (ARGO) and Dalhousie/NSHA breast cancer biobanks' will be processing and analyzed by the Genomics Core Facility at Dalhousie University. Clinical data is prospectively collected with specimen acquisition in the ARGO biobank. For the Dalhousie /NSHA biobank, clinical data will be retrospectively gathered from the medical record and migrated to an electronic database for prospective collection during the course of the study. Both cohorts of specimens will be run through DNA and whole transcriptome (mRNA) sequencing on the TSO500 platform (Illumina Ulc.). The tumor-immune microenvironment will be compared between cohorts and by mRNA cluster using the transcriptional signatures for 22 leukocyte populations and immune-regulating proteins CTLA-4 and PD-L1. Finally, tumor expression of DARC will be generated from the transcriptome data that will allow for an assessment of the relationship between DARC expression, TNBC mRNA clusters, and sociodemographic variables (i.e. race/ancestry, gender). Whole transcriptome data from The Cancer Genome Atlas will be pulled as the third cohort, including 55 TNBC specimens from African Americans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Triple-negative breast cancer

Exclusion Criteria:

* No diagnosis of Triple-negative breast cancer
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 20
* Informed consent

Exclusion Criteria:

* Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
* Known existing bleeding tendency (thrombocytopenia or prolonged INR)
* Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
* ASA class III or more
* Pregnancy
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.

This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:

Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.

Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.

During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women living in sample districts

Exclusion Criteria:

* Unable to provide informed consent
Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 18-100 years
2. Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
3. Must be able to read and understand English and consent for themselves.

Exclusion Criteria:

1. Allergy to TXA.
2. Acquired disturbances of color vision.
3. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
4. Pregnant or breastfeeding.
5. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
6. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
7. Refusal of blood products
8. Subarachnoid hemorrhage
9. Disseminated intravascular coagulation
Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS

This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting according to the approved label in Korea.

* Primary objective: To assess safety of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea
* Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea.

Eligibility Criteria:
* Inclusion Criteria:

  1. Eligible for, or on active study drug treatment according to the approved prescribing information;
* The first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
* Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have been previously treated with EGFR TKI therapy
* The adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
* Exclusion Criteria:

  1. History of hypersensitivity to the active substance or to any of the excipients of this drug
  2. Pregnancy and/or breast feeding
  3. Current participation in any interventional trial
Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale. Third objective: To compare the proportion of patients with positive treatment effects as determined by Modified Lanza scoring between the two groups.


Eligibility Criteria:
Inclusion Criteria:

Patients with rheumatoid arthritis and osteoarthritis who developed dyspeptic symptoms while on NSAID for at leat 4 weeks who fulfill any of the following criteria: 1) Have not been on NSAIDs (NSAID-naïve) as they are newly diagnosed patients or satisfies ALL of the following criteria: a) Have not received NSAIDs for more than 2 years continuously, b) Have not received NSAID for at least 3 months, c) Does not take more than the therapeutic dose required for any of the following NSAIDS: Aspirin (at max. 4000mg.day), Naproxen (at max. 1375mg/day), Ibupropen (at max. 2400mg/day), Diclofenac (at max. 200mg/day), Piroxicam (at max. 40mg/day). 2) Gastric mucosal lesions on upper endoscopy (Lanza score ≥ 1) 3) More than 18 and less than 65 years old 4) Medically cleared and consents to undergo upper endoscopy 5) Willing to participate in the trial and sign an informed consent form

Exclusion Criteria:

1. Patients with known malignancy 2) Women who are pregnant and breastfeeding 3) Psychiatric illness 4) severe co-morbid illness like renal failure, cirrhosis, etc. 5) History of intake of any anti-secretory agent for the past 2 weeks 6) Patients with coagulation disorders and hematologic problems 7) Complicated ulcers, i.e. bleeding, perforating, etc. 8) Patients with evidence of portal hypertension i.e. varices, portal gastropathy, etc. 9) History of gastric surgery 10) Patients on COX-2 inhibitors 11) Modified Lanza score of 0 12) Herbal medications or complementary alternative medicines (e.g. glucosamine chondroitisulfate, etc. 13) (+)H.pylori test by RUT (Rapid Urease Test) and biopsy.
Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib

The goal of this observational study is to to identify the demographic and clinical characteristics associated with the development of diarrheal adverse events in a Caucasian population with IPF undergoing treatment with nintedanib. Additionally this study aims to evaluate the different therapeutic strategies for dose reduction of nintedanib and assess the effectiveness of these strategies in reducing the occurrence of diarrhea.

The study population will consist of patients treated with Nintedanib for IPF who are followed at the Interstitial Lung Disease Outpatient Clinic of the Pneumology and Respiratory Intensive Care Unit at the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Policlinico di Sant'Orsola, and who have received the treatment for at least 12 consecutive months.

At the first available visit (which will be conducted according to the routine follow-up schedule), informed consent for participation in the study will be obtained. Following the signing of the informed consent, the data of interest for the protocol will be collected retrospectively, concerning the visit at which nintedanib therapy was initiated and the follow-up visits conducted at 6 and 12 months from the start of the antifibrotic therapy, as per clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian ethnicity;
* Age ≥ 18 years;
* Subjects with a diagnosis of IPF who started antifibrotic therapy with nintedanib on or after 01/06/2020.
* Obtaining written informed consent

Exclusion Criteria:

* clinical and functional data not availbale