cyrilzakka/clinical-trials huggingface dataset:
Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.

PRIMARY OBJECTIVE:

I. To analyze the characteristics, utility, and impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM).

OUTLINE:

Patients' medical records and past imaging examinations are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 or older
* Consecutive cases in breast imaging center

Exclusion Criteria:

* Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)
Improved Patient Recovery After Anesthesia

The proposed study will measure the incidence of adverse events and the decrease in time to meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea are used during emergence.

Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. The benefits of accelerating patient recovery in the operating room may extend to the post anesthesia care unit if the patient is more alert and easier to care for when they arrive in the unit. Respiratory patterns and gas levels - including CO2, O2, and anesthetic vapor - will be measured in order to better understand a patient's respiratory status during recovery.

In Feb 2009 we finished our first study (IRB 26111) and submitted a publication. The journal reviewers identified a serious limitation: we could not report whether the treated patients recovered from anesthesia faster because the treatment (inspired CO2) caused them to breath more vigorously or because the treatment caused the anesthetic vapors to be cleared more rapidly from the brain. Our new application uses essentially the same study protocol as the former study but adds chest bands to measure the patient's rate of breathing and expired gas monitoring to measure the rate at which the vapors are removed.

Eligibility Criteria:
Inclusion Criteria:

* adult ASA class I-III subjects of both genders scheduled to undergo eye surgery at the Moran Hospital.

Exclusion Criteria:

* a history of renal or hepatic disease, chronic alcohol or drug abuse, disabling neuropsychiatric disorder, hypersensitivity, or unusual response to other halogenated anesthetics, pulmonary hypertension, increased intracranial pressure, seizure disorder, or personal/familial history of malignant hyperthermia, and current smokers.
* Subjects will also be excluded if they are currently being treated with known hepatic enzyme-inducing drugs (e.g., phenobarbital, dilantin, or isoniazid) or with drugs known to alter anesthetic requirements (e.g., opiates, clonidine, alpha2 agonists, alcohol, anticonvulsants, antidepressants, barbiturates, benzodiazepines or other tranquilizers).
* Subjects will also be excluded if they have intolerance to non-steroidal anti-inflammatories.
* In addition subjects who have received general anesthesia within the previous 7 days, received any investigational drug within the previous 28 days, or participated in a previous isoflurane or desflurane study will be excluded.
* Female subjects can be neither pregnant nor breast feeding.
* Subjects with significant restrictive lung disease will also be excluded.
* Subjects passing these criteria will be further evaluated with a medical history including medications, abbreviated physical examination, clinical laboratory tests (urine drug test), and a urine or serum human chorionic gonadotropin pregnancy test for women with childbearing potential.
T-GENVIH-003 LTFU (Long Term Follow Up) Study

The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.

The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs from a sub-population of twenty-one participants from the previous T-GENVIH-002 study, specifically those with laparoscopic or robotic repair. Prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in T-GENVIH-002 to present.

Eligibility Criteria:
Inclusion Criteria:

* Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using Integra® Gentrix® Surgical Matrix.
* Subject has participated in the informed consent process and signed a study-specific informed consent document.
* Subject is fluent in US English or US Spanish language.
* Subject is willing to complete an e-consent and phone or in-office visit.

Exclusion Criteria:

* Not applicable.
Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. On the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. This study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor \[EGFR\] IgG1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. The primary endpoint is the objective response rate evaluated by imaging methods. The second endpoints are the progression-free survival and overall survival. The treatment toxicity is regarded as one the second endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Female aged more than 18 years
* Eastern Cooperative Oncology Group score 0-1
* Pathological confirmed of uterine cervical squamous carcinoma
* An interval of 3 months or more since the fulfilling of last treatment
* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
* Anticipative survival period of 3 months or more
* Lab testing within reference ranges
* With appropriate contraception
* Provided consents of participating the trial

Exclusion Criteria:

* With a history of exposure to other antiangiogenic agents
* With other malignancies within past 3 years
* With vital complications
* With uncontrolled hypertension despite of medical treatment
* With brain metastasis
* With addiction to psychiatric medications or with mental disorders
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency

The study aims to investigate the prevalence of genetic polymorphisms in adults with iron deficiency and anemia, and the responses to two different treatments: iron sulphate and a composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will be hemoglobin, measured before and after 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y and \< 50 y
* A diagnostic of iron deficient anemia

Exclusion Criteria:

* Severe anemia
* Treatment interruption for more than 25% of the 6 weeks
* New onset severe adverse symptoms or events
* Patient's request
Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Male/female, 18 yr or over
* WHO status 0-2
* Refractory advanced solid tumor

Exclusion Criteria:

* Radiotherapy within 4 weeks of starting AZD2171 treatment
* Low haemoglobin level
* Low platelet or neutrophil counts
Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors


Eligibility Criteria:
Inclusion criteria:

* Patients ≥18 years of age
* Histologically documented diagnosis of malignant MPNST
* Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.

Exclusion criteria:

* Patient has received any other investigational agents within 28 days of first day of study drug dosing.
* Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
* Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
* Known CNS metastases

Other protocol-defined inclusion/exclusion criteria may apply.
Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects

The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .


Eligibility Criteria:
Key Inclusion Criteria:

* 23kg/m2 ≤ BMI \<40kg/m2.

Key Exclusion Criteria:

* A history of thyroid disease.
* A positive HBsAg, HCV Ab and/or HIV Ab.
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking

The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success.

The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who applied to the smoking cessation clinic for smoking cessation
2. over the age of 18
3. Those who agree to answer the health literacy scale form

Exclusion Criteria:

1. Patients under the age of 18
2. Those who do not agree to answer the health literacy scale form
Early Treatments for Preventing Occlusal Caries Lesions

Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.


Eligibility Criteria:
Inclusion Criteria:

For children:

1. Children presenting with good general health and cooperative behavior.
2. Children having early caries lesions in a permanent molar (first or second).
3. Parents signed informed consent.

For permanent molars:

1. Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\].
2. Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). \[Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9\].

Exclusion Criteria:

For children:

1. Any allergy reported by the parents.
2. Children unable to return for recall visits.

For permanent molars:

1. Teeth with occlusal surfaces completely covered by the gingival tissue.
2. Teeth with hypoplastic defects, restorations, or sealants.
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).

This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.

Eligibility Criteria:
Main Inclusion Criteria:

1. Age 18 years or older of any gender.
2. Inpatients and/or outpatients who are able to attend all scheduled visits.
3. Patients with the first episode or the first recurrence of mild or moderate CDAD.
4. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

Main Exclusion Criteria:

1. Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
2. A white blood cell count higher than 15,000 cells/mL.
3. A serum creatinine level greater than or equal to 1.5 times ULN.
4. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
5. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
6. Any other non-C difficile diarrhea.
7. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
8. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
9. Received laxatives within the previous 48 hours.
10. Pregnant or lactating women.
11. Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
12. Have received a vaccine against C difficile.
13. Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.
Studies of Immune Responses in Patients With Chronic Hepatitis B

Taiwan is a hyperendemic area of hepatitis B virus (HBV) infection. Previous studies demonstrated vigorous T cell responses to HBV-encoded antigens developed in patients with self-limited acute hepatitis B. In contrast, weak or no T cell responses could be detected in chronic hepatitis B (CH-B) patients. However, these immune responses are still not well known in patients with acute exacerbation (AE) of CH-B and in patients with advanced liver diseases, such as liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The CD4+CD25+ regulatory T cells might suppress immune responses against foreign antigens and pathogens. The roles of CD4+CD25+ regulatory T cells in patients chronically infected with HBV remain to be clarified. The high percentage of HBV carriers in Taiwan are related to the vertical transmissions. High maternal HBV viral load may make the newborns tolerant to the HBV. However, the HBV-specific CD8+ T cells responses in the cord bloods of newborns are still unknown. Thus, we want to resolve these issues in this study. We will enroll the HBsAg (+) patients from NTUH. Blood samples will be collected. We will then analyze the HBV-specific CD8+ T cell responses and the clarify the roles of regulatory T cells.

The HBsAg (+) patients from National Taiwan University Hospital will be included. Screening for HLA haplotype will be performed by amplification refractory mutation system / PCR method. The HLA-A2 or HLA-A11 will be enrolled to the study group because these two haplotypes are the most ones in Taiwan. The other HLA haplotype HBV carriers will be enrolled as HLA-mismatch control. The disease spectra include inactive HBV carrier, CH-B, CH-B with AE (defined as ALT \>= 5 X UNL), HBV-related LC, HBV-related HCCs.

HBsAg, anti-HBs, IgM anti-HBc, HBeAg, anti-HBe, anti-HCV, anti-HDV, anti-HIV will be determined by commercial enzyme immunoassay kits. The serum levels of HBV DNA and genotypes will be done by quantitative real-time PCR. Patients who are also infected with HDV or HCV or HIV will be excluded.

PBMCs will be isolated from heparinized blood samples by density gradient centrifugation on Ficoll-Hypaque. The PBMC will be washed with phosphate-buffered saline (PBS) and resuspended in T cell medium.

Analysis of HBV-specific CD8+ T cell responses will be done by flow cytometry using pentamer staining.

To analyze HBV-specific CD8+ T cells responses in patients with chronic HBV infection (prospective study). This part of the study is to clarify the role of HBV-specific T cell responses during the course of acute exacerbation of CH-B. Blood will be collected at four important time points.

Eligibility Criteria:
Inclusion Criteria:

* patients chronically infected with hepatitis B virus

Exclusion Criteria:

* coinfected with HCV or HIV
Home Support for Mothers Whose Premature Infants

Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.

The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p \<0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.

Eligibility Criteria:
Inclusion Criteria:

* The infant was born prematurely (37 weeks of gestation + 6 days earlier),
* Does not have advanced congenital anomalies in the baby,
* Who will carry out the primary care of the infant at home,
* Reading and writing,
* Can speak and understand Turkish,
* Mothers who agreed to participate in the study

Exclusion Criteria:

* Incomplete filling of the forms
* Mothers who previously had training in newborn care
Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneﬁcial eﬀects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the eﬀect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the eﬃcacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Diagnosed of relapsing remmiting multiple sclerosis
3. Relapse free in the past 30 days
4. Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)
5. Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction
6. Internet and email access
7. Willingness to complete the questionnaires, wear the pedometer, and undergo randomization
8. Insufficient physical activity \[not meeting current physical activity guidelines based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ)\]
9. Ability to ambulate without assistance \[self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)\]
10. Age between 18 and 45 years
11. English as primary language

    -

    Exclusion Criteria:

1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise

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