cyrilzakka/clinical-trials huggingface dataset:
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.


Eligibility Criteria:
Inclusion Criteria:

* Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
* Patient did not withdraw from the base protocol
* Patient agrees to practice effective birth control during the study

Exclusion Criteria:

* Patient is receiving other standard and/or investigational anticancer therapy
* Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
The Problem of Colorectal Anastomosis Safety

This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year
* signed written consent
* a colorectal anastomosis lower 15 cm from anal verge
* elective surgery

Exclusion Criteria:

* allergy to indocyanine green dye
* pregnancy
Safety and Efficacy of L-NAME and Midodrine to Increase MAP

After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.

Blood pressure regulation is compromised in persons with tetraplegia due to de-centralization of sympathetic cardiovascular control, associated with hypotension during upright positioning (7, 10, 18, 33). An alpha receptor agonist (midodrine hydrochloride) has been reported to raise blood pressure in persons with tetraplegia (25, 26, 30). Midodrine is the only drug that is presently available to treat orthostatic hypotension. In the clinical armamentarium, it is always beneficial to have agents from multiple drug classes to treat a condition. In the treatment of hypertension, several classes of drugs may be prescribed to lower blood pressure, alone or in combination. The clinician and patient would benefit if another class of drug, with a totally separate mechanism of action, were available to treat orthostatic hypotension. A nitric oxide synthase inhibitor (NOSi), nitro-L-arginine methyl ester (L-NAME), has been shown by our group to "normalize" blood pressure in persons with tetraplegia (32). The safety and efficacy of these two hypertensive agents has not been investigated or compared in persons with chronic tetraplegia. Although the mechanism of action of each of these agents is appreciated, the relative cardiovascular effect in persons with SCI compared with controls is not known. The study will determine the efficacy and safety of these two medications at restoring mean arterial pressure (MAP) during daily activities in persons with chronic tetraplegia. Furthermore, the implication of restoring MAP to normal levels (80 10 mmHg) in individuals with tetraplegia on cardiovascular, autonomic, hormonal and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

Spinal Cord Injured Subjects:

* chronic spinal cord injury (1 year post injury) with a seated MAP of 65mmHg (almost all individuals with tetraplegia demonstrate this)
* Male or female with an age of 18 - 65 years

Control Subjects:

* Male or female with an age of 18 - 65 years

Exclusion Criteria:

Spinal Cord Injured Subjects:

* acute illness
* cardiovascular disease
* renal disease
* medications that affect the cardiovascular system

Control Subjects:

* acute illness
* cardiovascular disease
* renal disease
* medications that affect the cardiovascular system
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.

In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre.
* Residents of the study area
* Subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy.
* Subjects with the complete and relevant medical records available.

Inclusion criteria for the Exposed cohort:

* Subjects who received one dose of Refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in Brazil, and according to the program recommendations from May 2015 onwards.
* Subjects with appropriate vaccination records.

Inclusion criteria for the Unexposed cohort:

* Subjects who had delivered in the same hospital (study centre) before 01 September 2014 (September 2012-August 2014) and who did not receive Tdap vaccination during pregnancy to the best knowledge of the investigator.

Exclusion Criteria:

* Subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).
Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. The secondary outcomes were duration of cervical dilatation, up to Hegar number 10, complications during cervical dilation and the hysteroscopy, and misoprostol associated side effects. The cervical width was assessed by performing cervical dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilatators until the dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.

The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that equivalence was of clinical significance if the difference in the initial cervical width was less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6 mm. The estimated sample size was 47 patients in each group; this would be able to detect an equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of cases.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients that were suspected as having intrauterine pathology such as submucosal myoma, endometrial polyps or other endometrial pathological findings based on the transvaginal ultrasound were enrolled.
* women who are more than 20 years of age with having sexual contact history
* women whose last menstrual period are within the last two months.

Exclusion Criteria:

* Post menopausal women
* any evidence of a contraindication or allergy to PGs
* any sign of genital infection, history of cervical surgery, endometrial lesions with suspected endo- or exocervical lesions that could affect the cervical resistance or patients that were not candidates for surgery.
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Primary Objective:

• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.

Secondary Objectives:

* To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations
* Levels of cfDNA and its association with both EFS and OS in patients receiving therapy

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.
2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
3. Provision of written informed consent for the study.
4. Pregnant women not included
5. Cognitively impaired adults are not included.

Exclusion Criteria:

None
Polycolistin E Sodium Mesylate Combined With Intravenous Atomization for Carbapenem Resistant Gram-negative Bacteria in Pulmonary Infection

Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection symptoms. With the increasing use of broad-spectrum antibiotics in clinical practice, the failure of anti-infection caused by drug-resistant bacteria is more and more common. Once a patient develops carbapenem-resistant gram-negative bacteria (CRO) infection, there are limited drug options. Therefore, HAP, as a serious and common complication, has a high incidence and mortality for ICU patients. In this study, patients who met the diagnostic criteria for pulmonary infection caused by CRO that was clearly or strongly suspected to be resistant to carbapenems but sensitive to CMS were selected, and the combined treatment regimen of CMS intravenous atomization was adopted. To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection. To evaluate the safety and tolerability of the combination regimen in patients with pulmonary infections caused by CRO. The purpose of this study was to explore the efficacy and safety of CMS combined with intravenous atomization in the treatment of patients with CRO induced pulmonary infection, and to provide a basis for its clinical rational application.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the study and sign the informed consent;
2. Inpatients aged 18-80 years old, regardless of gender;
3. Patients who met the diagnostic criteria for pulmonary infection in the Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia for Adults in China (2018 Edition);
4. Infections caused by Gram-negative bacteria (CRO) that are known or strongly suspected to be resistant to carbapenems but sensitive to CMS.

Exclusion Criteria:

1. Age \> 80 years old;
2. The patient had a history of severe allergy or hypersensitivity to polymyxins;
3. Patients with serious dysfunction of heart, liver, kidney and other important organs;
4. Patients with serious diseases such as malignant tumors and blood system diseases;
5. Patients with low immune function and risk of opportunistic pathogen infection;
6. Patients who used excessive colistin intravenous or atomized inhalation therapy within 72h before enrollment;
7. Have participated in other clinical trials within three months;
8. Pregnant or breastfeeding women;
9. There are other circumstances that the researcher believes are not suitable for inclusion.
Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract
* Potential postoperative visual acuity of 1.0 Snellen
* No relevant ocular pathology other than cataract
* Written informed consent to surgery and participation in the study

Exclusion Criteria:

* Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
* Optical media disturbances due to: corneal and vitreal opacity, PEX
* Preceding ocular trauma or ocular surgery within 6 months
* Inability to cooperate
* Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)
Follicular Fluid Fetuins in in Vitro Fertilization

This study aims to investigate whether follicular fluid concentrations of fetuin A and fetuin B are associated with the clinical pregnancy and live birth rates in in vitro fertilization (IVF) cycles.Twenty-nine women with poor ovarian reserve (poor responders) and 33 women with polycystic ovary syndrome (hyper responders) who consecutively underwent IVF at a private hospital between May 2018 and February 2019.Fetuin A and fetuin B in follicular fluid were significantly lower in women who had clinical pregnancy than women who had no clinical pregnancy (p=0.001 for both)


Eligibility Criteria:
Inclusion Criteria:

Poor ovarian reserve patients and patient with polycystic ovary syndrome

Exclusion Criteria:

Normoresponders
Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI's)

To investigate if administration of probiotics, either orally or vaginally,

* Can reduce the number of episodes of acute bacterial cystitis and/or
* Has tolerable adverse effect profile
* Improves general QoL in these women
* Improves the immune function and other physiological stress markers
* Reduces inflammation in urinary bladder epithelium

Chronic recurrent bacterial cystitis is a condition that is disabling to a great extent and which influences quality of life and freedom of movement. The episodes can be painful, and lead to extensive use of antibiotics, which in itself promotes development of bacterial strains increasingly resistant to antibiotics, but do not prevent relapses. Almost all cystitis' in women are ascending infections from bacteria in the vagina, following colonization from the rectum. There have, however, been reported indications that there may be bacteria colonies within the urothelium that might give rise to relapses of the infections, rather than pure reinfection from ascending pathogens.

Probiotics are cultures of viable microorganisms, which show a positive effect on the general condition of the host when administered. Among the lactic acid bacteria (LAB), lactobacilli are the most commonly used for probiotics, and they have an excellent safety record. In terms of UTI, weekly or twice weekly intravaginal instillation of Lactobacillus strains GR-1 and B-54 have led to reduced recurrences. This concept has been supported by a 2006 pilot study showing that intravaginal administration of Lactobacillus crispatus GAI 98322 every two days for one year, had the potential to reduce the UTI recurrences. Another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina. The studies have shown that L. rhamnosus GR-1 and L. reuteri (formerly fermentum) RC-14 can reach the vagina after daily oral ingestion, and they can lower the bacterial and yeast pathogen numbers.

The aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause UTI.

Eligibility Criteria:
Inclusion Criteria:

* women 18-70 years old
* spontaneous urination
* \> 3 UTI's previous year
* no ongoing prophylactic antibiotic treatment

Exclusion Criteria:

* \> 50 ml residual urine
* neurological bladder disease
* known neoplasia, kidney stone or urinary tract abnormalities
* use og indwelling catheter
* pregnancy
* diabetes
* infrequent voiding pattern
* symptoms that indicate interstitial cystitis
* creatinin \> 250 micmol/L
* participating in other clinical trial
CRYoablation for Small Tumors As Local Treatment - SIX Trial

To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.

This study compares cryoablation with breast surgery for the treatment of early-stage breast cancer (T1N0M0), evaluating locoregional recurrence, cost-minimization, and disease-free survival.

The primary objective is to demonstrate the non-inferiority of cryoablation compared to breast surgery for local treatment of early-stage breast cancer over five years, as well as to perform a cost-minimization analysis to compare the direct costs of both treatments over one year.

The secondary objectives include assessing locoregional recurrence at one year, evaluating disease-free survival and overall survival over five years, analyzing circulating tumor cells (CTCs) as prognostic factors and for monitoring cryoablation at baseline (study inclusion), six months, and twelve months, measuring patient satisfaction one year after randomization using the Breast-Q questionnaire, and assessing quality of life using the EQ-5D questionnaire.

Cryoablation is a nonsurgical, minimally invasive technique that destroys tumor tissue through cyclic freezing and thawing using cryoprobes. This process induces cellular death without requiring hospitalization, allowing for faster recovery.

Additionally, the study incorporates a de-escalated and personalized approach to breast cancer treatment by omitting sentinel lymph node biopsy, integrating ultrahypofractionated radiotherapy, and utilizing liquid biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Unifocal primary invasive breast carcinoma
* Tumor size ≤ 2.0 cm (T1)
* Complete pathological report (including results for ER, PR, HER2, Ki-67, and FISH report for the ERBB2 gene, if necessary)
* Lesion visible on ultrasound
* Surgical treatment would be the first option, regardless of immunohistochemistry results

Exclusion Criteria:

* Multifocal or multicentric invasive breast carcinoma
* Ductal carcinoma in situ
* Breast cancer with skin involvement
* Clinically positive axilla (N1, N2 or N3)
* Distance from lesion and skin less than 5 mm
* Prior neoadjuvant systemic therapy for breast cancer
* Distant metastasis
A2R and Ectonucleotidases Expression in Lung Cancer Circulating Tumor Cells

Early non-small cell lung cancer (NSCLC), treated by surgery or radiotherapy in the case of inoperability, relapses in almost 50% of cases. Circulating tumour cells (CTCs), which can be detected before surgery, represent a promising prognostic tool, but the markers characterising their aggressiveness remain to be determined. The NSCLC microenvironment, in which purinergic signalling is a key pathway, controls tumour development. Adenosine derived from the action of CD39 and CD73 ectonucleotidases hydrolysing extracellular ATP, induces immunosuppression of NSCLC by activating A2R receptors. The expression and prognostic relevance of A2R, CD39 and CD73 on CTCs is unknown. The objectives are to (i) compare the expression of A2R and CD39 and CD73 on primary tumour cells and CTCs of patients operated on for early NSCLC, (ii) correlate these data with molecular characteristics and clinical response, (iii) determine on lung cancer lines whether irradiation impacts on the expression of A2R, CD39 and CD73. This work could contribute to the identification of new theranostic biomarkers.


Eligibility Criteria:
i) Inclusion criteria:

* Patient of legal age (\>18 years), any gender,
* operated on for stage (IA to IIB) non-small cell lung cancer (NSCLC)

ii) Exclusion criteria:

* Patient with any other active cancer.
* Lack of evaluable material.
A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
Evaluation of Sleep Apnea Related Inflammation With CRP, ESR and Neutrophil toLymphocyte Ratio

There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Detection of altered inflammatory markers in OSAS patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge, NLR has not been studied in OSAS. We conducted the present study to evaluate the association between OSAS and inflammatory markers CRP, ESR and NLR.


Eligibility Criteria:
Inclusion Criteria: Subjects who were referred for polysomnography (PSG) testing and performed the test were included Exclusion Criteria: Patients with malignancy, diabetes mellitus, dyslipidemia, cardiovascular disease or hypertension, chronic inflammatory processes, thyroid dysfunction, chronic hepatic disease, renal failure, any acute- subacute infectious disease within past 2 months, if data are incomplete such as blood sample testing results, if they were unable to perform complete PSG testing.

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