cyrilzakka/clinical-trials huggingface dataset:
TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.

The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years;
2. Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
3. Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion \>3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
4. Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
5. Eastern Cooperative Oncology Group scoring 0-1;
6. Child-Pugh A class;
7. At least 3 months of life expectancy;
8. Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN.

Exclusion Criteria:

1. Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden\>50%;
2. Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
3. Have contraindications for TACE;
4. Have metastasis in central nervous system;
5. Allergic to intravenous contrast agents;
6. Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
7. Infection of HIV, known syphilis requiring treatment;
8. Have a known history of prior invasive malignancies within 5 years before enrolment;
9. Patients with allotransplantation;
10. Severe dysfunction involving heart, kidney or other organs;
11. Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
12. Patients with mental disorders which may impact informed consent;
13. Unable to orally take drugs;
14. Participating other clinical drug trials 12 months before enrolment.
Colorectal Emergencies in Elderly Patients.

Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. The aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term.

From November 2020 to February 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. We have collected and analysed all demographic, and operative data and then applied CR-POSSUM score and correlated with postoperative hospital stay and the onset of postoperative complications according to Clavien Dindo classification.

Postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. There was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. The number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. The value of Operative Severity Score in the Bowel Perforations, was significantly higher.

The use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. The CR-POSSUM score was important for predicting morbidity in our study. Emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.


Eligibility Criteria:
Inclusion Criteria:

* age older than eighty
* emergency conditions

Exclusion Criteria:

* trauma cases
Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients

Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.

Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS. Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by March-May 2020, the patients over 18 years old who were in either intensive care or ward scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been collected from the written resources and electronic data retrospectively.

the patients who are diagnosed with Covid\*19 pneumonia will be divided into two groups. The ones in the ward will be considered as mild clinical course, and the ones in the intensive care unit will be considered as severe clinical course. there will be an additional non Covid individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT will be calculated using admission hemogrames of these groups, and the significance of the statistical differences on determining the prognosis of the disease will be discussed.

Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G\*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using ANOVA test between at least two independent groups. In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 52 patients which makes at total of 156.

The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA test. Categoric data will be compared by Pearson ki square test and the p values less than 0.05 will be considered as significant.

we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020

Exclusion Criteria:

* Under 18 years old patients
* Patients with heamolytic diaseses
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.


Eligibility Criteria:
Inclusion Criteria:

HCV Positive With HCV RNA\>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

Exclusion Criteria:

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP\>200ng/ml
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC


Eligibility Criteria:
Inclusion Criteria:

* Signed and written informed consent
* Age 18 year or older
* Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss on a biopsy of a metastatic lesion.
* Metastatic lesion accessible for histological biopsies
* Evidence of progression of disease
* A maximum of two lines of palliative chemotherapy
* WHO performance status of 0 or 1
* Evaluable disease or measurable according to RECIST 1.1

Exclusion Criteria:

* Leptomeningeal disease localization
* History of having received other anticancer therapies within 2 weeks of start of the study drug
* History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression
* Prior treatment with immune checkpoint blockade
* Live vaccine within 2 weeks prior to start of study
* Active other cancer
* Active hepatitis B
European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies

A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe


Eligibility Criteria:
Inclusion Criteria:

* Is male or female
* Has histologically or cytologically confirmed breast cancer diagnosis (HR+/HER2- breast cancer)
* Has received a diagnosis of locally advanced breast cancer not amenable to curative radiation or surgical cure or of metastatic breast cancer (i.e., advanced breast cancer \[ABC\]); diagnosis may be de novo (initial diagnosis at ABC stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease)
* Has initiated a required first-line therapy of interest: Palbociclib plus AI as first-line therapy for ABC between September 1, 2016, and July 31, 2020, or AI monotherapy as first-line therapy for ABC between January 1, 2010,, and July 31, 2020
* Was aged 18 years or older at the time of diagnosis of ABC
* Is living or deceased at the time of record abstraction
* Has a complete medical record, covering treatment for ABC, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction

Exclusion Criteria:

* The patient's first treatment after ABC diagnosis was chemotherapy (including induction chemotherapy)
* The patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of ABC; patients diagnosed with second primary cancer after ABC diagnosis will not be excluded
* The patient has evidence of prior treatment with any CDK4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the ABC setting
* The patient has participated in a clinical trial related to treatment of ABC (including after first-line therapy \[i.e., palbociclib plus AI or AI monotherapy\])
Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one-fourth report severe symptoms. It is unclear why patients' experience of AF-related symptoms varies so much. We have previously shown that patients with symptomatic AF exhibit lower pain tolerance than patients with asymptomatic AF, as well as impaired pain inhibitory control and facilitated summation of pain, indicating that pain sensitisation may be of importance in symptomatic AF. In patients with chronic pain conditions, several biomarkers and epigenetic markers associated with generation and /or maintenance of chronic pain have been identified. Previous research of biomarkers and epigenetic markers associated with pain is sparse in patients with AF.

The objective is to study levels of biomarkers and epigenetic markers in blood in patients with symptomatic paroxysmal AF (n=100), in relation to severity of AF symptoms, and compared to age- and sex-matched controls without AF (n=100). Blood will be obtained before and after AF ablation and levels of biomarkers, epigenetic markers and cardiac and inflammatory markers, analysed. Patients will complete an AF-specific symptom and a generic health-related quality of life questionnaire.

In the future, biomarkers and epigenetic markers associated with pain may be used as a tool for evaluation of patients with AF and have an impact on individualized management. Another possibility is a rationale for future studies of novel analgesics that neutralize biomarkers or antagonizes its receptors.


Eligibility Criteria:
Inclusion Criteria:

* On waiting list for AF ablation (only symptomatic subjects are offered ablation)
* Paroxysmal AF and persistent AF (AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion after ≥7 days)
* Written informed consent

Exclusion Criteria:

* Previous pulmonary vein isolation
* Cognitive or psychiatric condition
* Diabetes mellitus
* Ischemic heart disease
* Heart failure
* Asthma
* Pregnancy
* Previous/current drug or alcohol abuse
* Previous neurological or concomitant musculoskeletal disorders
* Continuous analgesic medication
Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2

Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.

Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer.

Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made.

Research staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received.

Eligibility Criteria:
Inclusion Criteria:

Age 45 or older Localized prostate cancer with a Gleason score of 6 or less

Exclusion Criteria:

Women
Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.


Eligibility Criteria:
Inclusion Criteria:

* Systemically in a healthy condition.
* Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
* Non-smokers.
* Good oral hygiene as indicated by plaque and bleeding scores

Exclusion Criteria:

* Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
* Acute maxillary sinusitis.
* Patients administering any antibiotics or regular anti-inflammatory drugs.
The Effect of Antacids and Multivitamins on Raltegravir

This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.


Eligibility Criteria:
Inclusion Criteria:

* The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
* ≥ 18 years
* Male or female subjects
* A female may be eligible to enter and participate in the study if she:
* Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
* Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy
* Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication
* Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
* Any intrauterine device (IUD) with published data showing that the expected failure rate is \< 1 % per year
* Any other method with published data showing that the expected failure rate is \< 1 % per year
* Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study
* Male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized
* All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)

Exclusion Criteria:

* Any significant acute or chronic medical condition
* Pregnant or lactating women
* Women of childbearing age unless using non hormonal contraception
* Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
* Abnormal LFTs (ALT \> 2.5 x ULN, bilirubin \> 1.5 x ULN)
* Positive blood screen for HIV-1 and 2 antibodies
* Positive blood screen for hepatitis B or C antibodies
* Current or recent (within 3 months) gastrointestinal disease
* Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects
* Use of proton pump inhibitors
* Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
* Consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study
* Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
* Previous allergy to any of the constituents of the pharmaceuticals in this trial
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.

This trial will be a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at IRCH, AIIMS will be taken into study after taking informed consent. Patients will be randomized into two arms. Each arm shall contain 20 patients. The patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ECOG performance status 0,1 and 2 3.Adequate hematologic, renal and liver functions 4.Informed consent 5.Measurable disease by CT scan or USG abdomen or MRI

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Exclusion Criteria:

1. ECOG performance status 3 or 4
2. Impaired blood counts: those patients with an absolute neutrophil count \<1,500/μL, platelet counts \<100,000/μL, will be ineligible.
3. Impaired renal /liver functions as indicated by:

Serum bilirubin \>1.5× normal, AST level more than 3× normal, Alkaline phosphatase level more than 3× institutional normal, or a Serum creatinine level more than 1.2 mg/dL. Patients with serum creatinine level of more than 1.2 mg/dL but less than 1.5 mg/dL are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 mL/min.

4. H/o prior chemotherapy for metastatic disease, 5. H/O concurrent or past malignancy other than carcinoma cervix, 6. CNS metastasis, or 7. Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy.

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