cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence.

Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

Eligibility Criteria:
Inclusion Criteria:

* Tumor within 6 cm of the anal verge, or with very narrow pelvis
* T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination
* Absence of distant metastases
* Absence of intestinal obstruction

Exclusion Criteria:

* T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination
* with distant metastases
* with intestinal obstruction
* pregnancy or lactation
* allergic constitution to heterogeneous protein
* with operation contraindication
* with mental disorder
Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions

The purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.

The purpose of this study is to compare the health outcomes utilizing home medical visits to manage hypertension and type 2 diabetes as compared to standard of care clinic visits.

This project has 3 overall objectives:

1. To test the efficacy of home medical visits by Family Medicine physicians specifically designed for patients with hypertension (HTN) and Type 2 Diabetes Mellitus (T2DM)
2. To compare primary outcome of the patients randomly selected for home visits to similar patients receiving usual care in the clinical setting
3. To understand the efficacy and impact of the home visit from the patient perspective

Study participant will receive usual care from a resident doctor in home. There will be (2) home visits conducted over the course of this study that will include a comprehensive assessment of hypertension, type 2 diabetes, and social factors that may be impacting their health. Study participants will also be asked to complete several questionnaires related to their knowledge of chronic diseases, personal health management, and experience of the study home visits.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ages 18-60
* Spanish or English speaking
* Diagnosis of HTN or BP \>140/90 in last 3 months (based on medical record)
* Hemoglobin A1C\>8 in last 6 months (based on medical record)
* Not pregnant

Exclusion Criteria:

* Current oral steroid use
* History of solid organ transplant
* Language other than English or Spanish
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
* Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
* Adequate tissue to calculate RSI
* To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
* To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (\<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
* Life expectancy \>16 weeks
* KPS ≥ 70
* Age ≥ 18 years
* Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
* There is no limit on prior systemic therapies
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
* Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment

Exclusion Criteria:

* Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
* Women who are pregnant or breastfeeding
* Positive surgical margins
* History of allergy or hypersensitivity to any of the study drugs or study drug components
* Metastatic breast cancer
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled \[14C\]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of \[14C\]-GDC-0973.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
* No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations
* Negative test for selected drugs of abuse
* No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
* Sterile or agree to use an adequate contraception method
* Historically able to produce a minimum of 1 bowel movement per day

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance unless approved by the Investigator
* History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed
* History of Gilbert's Syndrome
* History of diabetes mellitus and/or elevated fasting glucose at baseline
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction within 1 year prior Check-in
* Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
* Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in
* Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
* Use of any prescription medications/products within 14 days prior to Check-in
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Evaluate voice and swallowing outcomes post operatively.

Anterior Cervical Decompression and fusion is one of the most common spinal surgical procedures performed in the United States. Common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. The chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. The purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing revision anterior cervical spine surgery

Exclusion Criteria:

* Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.
Drug-Induced Sudden Death & Ventricular Arrhythmia

To investigate the relationship between the use of prescription drugs and the occurrence of ventricular arrhythmia and sudden death.

BACKGROUND:

Drug-induced sudden cardiac death (also called sudden death, SD) and ventricular arrhythmia (VA) have arisen as major public health concerns in the last decade. Sudden death/ventricular arrhythmia have resulted in the withdrawal of more drugs in recent years than any other adverse drug reaction, and the identification of over 100 non-cardiac drugs as suspected of being high-risk. Unfortunately, controlled studies measuring the risks associated with specific drugs are very few in number, presumably because of the complexity of such studies and the massive sample sizes needed to study this outcome. Even studies in "large" databases have lacked adequate statistical power for crucial subgroup analyses. This lack of controlled data on clinical sudden death/ventricular arrhythmia has necessitated reliance on uncontrolled observations and on studies of putative markers of risk such as QTc prolongation in the electrocardiogram. However, the utility of uncontrolled observations is always subject to question, and the validity of these putative markers remains unknown. As a result, clinicians, patients, regulators, and drug manufacturers are ill-equipped to address the critical clinical and public health decisions concerning drug-induced sudden death/ventricular arrhythmia.

DESIGN NARRATIVE:

This study will compile a massive new pharmacoepidemiologic database of Medicaid data (linked with Medicare data for those enrolled in both programs, and with the Social Security Administration Death Masterfile) from five large Medicaid programs. This will be combined with the UK General Practice Research Database. This combined database will be used to conduct a series of nested case-control and case-crossover studies to measure the absolute and relative rate of all-cause death and sudden death/ventricular arrhythmia (SD/VA) associated with five of the most commonly used drug classes of greatest concern: antipsychotics, antidepressants, opioid analgesics, quinolone antibiotics, and macrolide antibiotics. A multi-stage investigative strategy will be used: Stage 1 will compile the database, assure its quality, and reproduce known associations. Stage 2a will compare drugs among the classes of interest. Stage 2b will use the case-crossover design to look for associations controlling for stable patient factors. Stage 2c will examine the effect of dose and inhibitors of pharmacokinetic clearance, the functional equivalent of high-dose use. Stage 3 will develop predictive indices to stratify patient subgroups receiving high-risk drugs.

Eligibility Criteria:
This combined database will be used to conduct a series of nested case-control and case-crossover studies to measure the absolute and relative rate of all-cause death and sudden death/ventricular arrhythmia (SD/VA) associated with five of the most commonly used drug classes of greatest concern: antipsychotics, antidepressants, opioid analgesics, quinolone antibiotics, and macrolide antibiotics.
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.

This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen to 55 years of age, inclusive
* Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.
* Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .
* Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.
* Not pregnant as confirmed by a negative serum human chorionic gonadotropin

Exclusion Criteria:

* A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
* Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
* Abnormal endometrial biopsy within six months of starting study treatment.
* History of an endometrial ablation within 12 months of starting study treatment.
* Uterine artery embolization within six months of starting study treatment.
* Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
* Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
* Active pelvic infection or current use of an intrauterine device within three months of screening.
* Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.
* Any uterine dimension \>20 centimeter (cm).
* Other major causes of heavy menstrual bleeding -
* Use within 3 months or anticipated use of medications that modify reproductive function
* Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.
* Use of daily opioid pain medications other than with menses.
* Hemoglobin \<8 grams (g)/deciliter.
* History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).
The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.

The main questions it aims to answer are:

1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.

Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
2. Radical prostatectomy is planned;
3. Voluntarily sign the informed consent form.

Exclusion Criteria:

1. Diagnosed with other malignant tumors at the same time;
2. Patients with acute infection.
iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis

This study will look at the use and impact of smartphone application (app) for adolescents with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project will include three studies. First, the investigators conducted usability sessions with adolescents with JIA to refine the app so that it is usable, acceptable and understandable. The aim of this study is to look at (a) how regularly the "iCanCope with Pain" app is used and (b) any effect the app has on young people's health. This study will compare two groups of young people: one that is using the new app, and one that receives usual medical care.


Eligibility Criteria:
Inclusion Criteria

1. Aged 12-18 years
2. Diagnosed with JIA (36) as per their rheumatologist
3. Able to speak and read English
4. Have self-reported average arthritis-related pain in the past week of \>3 on 10cm visual analogue scale (VAS)
5. Willing to complete online study outcome measures

Exclusion Criteria:

1. Moderate to severe cognitive impairments as per their healthcare provider
2. Major co-morbid psychiatric \[conversion disorder, depression, anxiety disorder\] illnesses that may impact their ability to understand and use the "iCanCope with Pain" intervention as per their rheumatologist
3. Received more than 4 CBT sessions for pain management in the past 6 months, as per their healthcare provider and self-report
4. Patients from the department of haematology/oncology
Outcomes of Obstetric Patients With COVID-19 Disease in the ICU

Although several studies are conducted in the general population researching the clinical and laboratory parameters predicting the progression to severe disease in COVID-19, the data are very few in obstetric patients. Therefore,the investigators aimed to evaluate the characteristics, prognosis, laboratory parameters, and mortality of obstetric patients followed up in the intensive care unit (ICU) due to severe COVID-19 disease and to determine the factors affecting mortality.

This study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information were analyzed retrospectively from the patient files.

Demographic data, obstetric histories, comorbidities, treatments received in the intensive care unit (ICU), delivery types, anesthesia types, and outcomes of newborns and mothers were retrospectively evaluated from the medical records. The need for the mechanical ventilator, the length of stay in the ICU, and outcomes of mothers were recorded. Laboratory findings were noted on the first day of admission to the ICU, including routine complete blood count, liver and kidney function, coagulation parameters, C-reactive protein (CRP), and albumin levels. Then neutrophil to lymphocyte (N/L) ratio, platelet to lymphocyte (P/L) ratio, and CRP to albumin (CRP/Alb) ratio were calculated. Deceased patients were evaluated in detail.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital
* Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria:

* Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious
PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction

This clinical trial aims to compare the efficacy and safety of applying "PeptiCol EZgraft" in extraction socket preservation procedures against "Regenomer," in terms of reducing the amount of alveolar bone change during the healing process following tooth extraction.

The purpose of this clinical trial is to compare the efficacy and safety of using "PeptiCol EZgraft" in extraction socket preservation procedures against "Regenomer," specifically to evaluate whether PeptiCol EZgraft is more effective in reducing alveolar bone changes compared to Regenomer. The trial aims to assess both the effectiveness and safety of PeptiCol EZgraft in minimizing alveolar bone resorption during the healing process following tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 to 75 years.
2. Systemically healthy or with mild systemic disease, classified as ASA I or II.
3. Planning to place implants in the maxilla or mandible after extraction, or having such plans for the future. If there are multiple extraction sockets, only one socket will be included in the trial, and other areas will follow spontaneous healing or treatment plans.
4. The extraction socket area must have more than 50% of the alveolar bone wall remaining.
5. Willing to maintain good oral hygiene during the clinical trial.
6. Voluntarily decided to participate in the trial and signed the informed consent form.
7. Willing to participate for the entire duration of the clinical trial and comply with trial procedures.

Exclusion Criteria:

1. Extensive alveolar bone absorption observed in the extraction socket area.
2. Severe periodontal disease or acute periodontal abscess.
3. Poor oral hygiene.
4. History of bone grafts or implants in the area of the medical device application.
5. Mucosal diseases due to autoimmune disorders.
6. History of hypersensitivity to collagen preparations.
7. Smoking more than 10 cigarettes per day.
8. Alcohol or drug addiction.

   \*The alcohol addiction screening will be conducted using AUDIT-K.
9. Use of drugs affecting bone formation within 2 weeks prior to screening (e.g., steroids, bisphosphonates).
10. Use of oral or injectable rheumatic medications, including immunosuppressants, within 2 weeks prior to screening.
11. History of or current use of oral or injectable bisphosphonates for osteoporosis for more than 12 weeks.
12. Uncontrolled bleeding disorders or use of medications affecting blood coagulation.
13. Uncontrolled diabetes or hypertension.
14. Clinically significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system diseases observed at screening.
15. Immune disorders including acquired immunodeficiency syndrome.
16. Pregnant or breastfeeding women
17. During the clinical trial period, female and male participants who are of childbearing potential must agree to use appropriate contraception from the date of signing the informed consent form until the end of the clinical trial (16 weeks post-procedure). If a female participant becomes pregnant during the trial period, her participation will be discontinued.