cyrilzakka/clinical-trials huggingface dataset:
Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance.

The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV.

Background: Heart rate variability (HRV) measurement is widely used to assess the function of cardiac autonomic modulation. Aerobic exercise (AE) has been proven to improve HRV. However, because HRV is highly associated with visceral fat, inflammatory status, and insulin resistance, whether baseline body inflammation status can explain the heterogeneous response to AE remains unknown.

Purposes: We will compare the effects of AE training in improving HRV, inflammatory markers, and insulin resistance between community residents with normal weight and overweight/obesity.

Methods: A quasi-experimental study with purposive sampling will be used to recruit community residents aged 40-64 years with inactive habits in southern Taiwan. The minimum targeted sample size is 43 participants. The participants will be grouped into normal weight and overweight/obese groups. All participants will receive AE training with at least moderate intensity three times per week. HRV parameters, blood samples, and visceral fat will be evaluated. The blood samples will be evaluated for C-reactive protein and markers of insulin resistance (fasting glucose, insulin). All participants will be evaluated at baseline (T0) and after a 16-week intervention (T1). In addition to these time points, HRV will be measured during every exercise session for participants in exercise groups. Generalized estimating equations will be used to determine whether baseline BMI is the key factor influencing the effects of AE.

Relevance to clinical practice: The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV.

Eligibility Criteria:
Inclusion Criteria:

* are aged between 40 and 64 years.
* had inactive habit (\<3 days of physical activity per week and \<30 minutes per session).
* can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* underlying conditions, such as stroke, acute coronary artery diseases, handicap, pregnancy, and unstable hypertension, that may present risks for exercise training.
* smoking or alcohol abuse.
* currently being on a diet, and (d) lifestyles that may affect HRV and inflammatory biomarkers (e.g., shift work or habit of staying up late).
Intramural Needle Ablation for Ventricular Tachycardia

This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.

This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.

Data Collection:

Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.

Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.

Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.

Exclusion Criteria:

* Patient refusal to participate
Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study

Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectopexies between January 2014 and June 2018 at H.S.U Kocaeli Derince Training and Research Hospital Gynecology and Obstetrics clinic were re-examined between 15 June and 30 December 2018 gynecologically.

Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectocolpopexies were re-examined 7 to 43 months after surgery. All of the women had undergone surgery for stage 2 or greater uterovaginal or vaginal vault prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.

All of the patients received telephone calls and were invited for a gynecological re-examination. All but one patient in the vaginal surgery group came in for a gynecological control. We conducted a phone interview with the one patient not agreeing to come to the control, and we learned that she had a relapse 6 months after the operation. She underwent another prolapse surgery at a different hospital. She described her postsurgical complaints, and we noted that she was unsatisfied with the surgery. In the postoperative re-evaluation between 15 June and 30 December 2018, all of the women were examined in the lithotomy position for apical, anterior, and posterior compartment descensus. Stage 2 or greater apical descensus or a cystocele or rectocele according to the POP-Q system were accepted as postoperative relapses. All of the patients answered the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and Prolapse Quality of Life (P-QOL) questionnaire. All of the women were asked about de novo urge urinary incontinence and de novo stress urinary incontinence. In addition, each patient's satisfaction with the surgery was asked and recorded.

Eligibility Criteria:
Inclusion Criteria:

Those patients with stage 2 or greater uterovaginal/vaginal cuff prolapses according to the POP-Q system underwented to surgery (vaginally or laparoscopically) between January 2014 and June 2018 were included to the study.

Exclusion Criteria:

Women who had surgeries for malignancy suspicion or pelvic inflammatory disease and women with pectouteropexy procedure were not included into the study.
Decrease of Libido of Post-Operative Male-Female Transsexuals and a Healthy Female Control Group

Participants fill out a questionnaire on libido and their possible partner relationship.

A blood sample is taken for sex steroid analysis.

Participants fill out a questionnaire on libido and their possible partner relationship on the website http://www.onderzoek-libido.be.

A blood sample is taken for sex steroid analysis. The relation will be investigated between testosterone, free testosterone, sex hormone binding globulin, estradiol, DHEA and androstenedione and scores on relational and sexual satisfaction and sexual desire.

Eligibility Criteria:
Inclusion Criteria:

* Transsexual women with completed adaptation of the sex (all surgical procedures and hormonal treatments)
* The female control group must be 18-45 years
Vancomycin De-escalation Therapy in Patients With Pneumonia

This is a non-inferiority study evaluating clinical improvement rate when using MRSA nasal swabs to guide discontinuation of vancomycin for empiric coverage for MRSA pneumonia.

Current clinical guidelines recommend including vancomycin in initial empiric therapy if risk factors for MRSA infection are present, or there is a high incidence of MRSA locally. Prolonged exposure to vancomycin, however, has been linked with the risk of vancomycin-associated kidney failure. Studies have reported that a MRSA nasal swab may be used to predict the presence of MRSA pneumonia. Specifically, pneumonia patients with negative MRSA nasal swabs are 95-99% likely to not have pneumonia due to MRSA. There is limited data, however, evaluating the use of a MRSA nasal swab to guide vancomycin therapy. Accordingly, in this study, pneumonia patients in the intervention arm will have empiric vancomycin discontinued following a negative MRSA nasal swab. In the control arm, patients vancomycin will not be discontinued based on the MRSA nasal swab result. The rate of clinical resolution will be compared between these two study arms.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Patients admitted to Charleston Area Medical Center (CAMC) through the Emergency Department who meet the CDC criteria for pneumonia.
* Nasal surveillance culture for MRSA obtained in the Emergency Department
* Patients receiving vancomycin and additional antibiotic therapy for gram-negative coverage

Exclusion Criteria:

* Persistent vasopressor requirements when MRSA nasal swab results are available
* Patients not meeting the CDC criteria for pneumonia
* Patients presenting to the ED with leukopenia (≤4000) without previous documentation of normal or elevated WBC
* Patients receiving empiric MRSA antibiotic therapy other than vancomycin for pneumonia
* Patients with the diagnosis of lung abscess
* Patients not receiving vancomycin therapy before MRSA nasal swab results are reported
* Immunocompromised individuals. i.e. patients with AIDS/HIV, vasculitis on immune suppressor therapy, steroid therapy for more than one week prior admission or who received chemotherapy in the last 3 months
* Patients who do not have a MRSA nasal swab obtained in the ED
* Nares swab obtained after the completion of the first administered dose of an antibiotic with activity against MRSA
* Patients with MRSA bacteremia
* Patients with chronic tracheostomy
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.


Eligibility Criteria:
Key Inclusion Criteria:

* Is in good general health as determined by Investigator's review.
* Has a body mass index (BMI) between 18 and 35 kg/m2.
* Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
* For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
* For males, must agree to use barrier contraception and not to donate sperm

Key Exclusion Criteria:

* Is pregnant, lactating, or planning a pregnancy during the study.
* Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
* History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
* Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).

Key Inclusion Criteria- PDN Cohort

* A diagnosis/history of Type 2 diabetes mellitus
* The pain is present in both feet/legs with symmetrical onset
* The pain is characterized as burning, painful, cold or electrical shocks in nature
* The pain is associated with tingling, numbness, itching or pins and needles type sensations
* The pain has been present and consistent for ≥ 6 months

Key Exclusion Criteria- PDN Cohort

* Diagnosis of Type 1 diabetes
* Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness
* Has a history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has a History of psychological conditions or neurological disorders
* Has a History of lower back pain with radiculopathy
* Has received non-pharmacological treatment for pain within 14 days
* Has a history of frequent and/or severe allergic reactions with multiple medications
Asacol Acute Diverticulitis(DIVA)Study

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of acute diverticulitis
* Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception \[at least 3 months prior to enrollment\]; 2-barrier methods \[e.g., condom, diaphragm, or spermicide\]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
* Willing and able to participate in the study and provide a signed informed consent

Exclusion Criteria:

* Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
* Active or recent history (within 6 months) of a peptic ulcer;
* Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
* History of major abdominal surgery (as determined by the Investigator);
* History of GI surgery within 3 months of diagnosis of acute diverticulitis;
* History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
* If female patient, active or recent history of endometriosis or dysmenorrhea;
* Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;
An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network

A Multi-centre Observational Study to Evaluate the Clinical Utility of Returning Genomic Aberration results Using the Oncomine Precision Assay in Advanced or Metastatic Non-Small Cell Lung Cancer Patients within the Exactis Network

This prospective multi-center observational study will evaluate the clinical utility of returning genomic aberration results in blood and/or tissue using the Oncomine Precision Assay in non-small cell lung cancer (NSCLC) patients. Up to 100 patients with stage IIIb/IV NSCLC will consent to have their blood and tissue profiled on the Oncomine Precision Assay. A baseline plasma sample will be collected for all patients, of which up to 50 patients will have a tissue sample collected from pathology archives or planned biopsy or surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NSCLC, which is (i) advanced or metastatic (stage IIIb/IV), (ii) non- squamous histology NSCLC as confirmed by local histopathology (mixed squamous and adenocarcinoma is allowed), and has (iii) radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm by CT scan
* No prior treatment for advanced or metastatic NSCLC, except for palliative radiation therapy to non-lung or non-thorax metastases. Patients who received palliative radiation therapy to metastases located within or approximately to the lung or thorax must be evaluated for eligibility.
* Willing and able to provide adequate blood sample prior to starting treatment.
* Willing to provide primary or metastatic tissue, if available.
* Signed and dated Research Ethics Board (REB)-approved informed consent form for Exactis-01 or PMT.
* Not pregnant or breastfeeding

Exclusion Criteria:

• Patients who have a history of another active cancer within the past 2 years from date of consent except cervical cancer in situ, basal cell carcinoma of the skin or another in situ carcinoma that is considered cured by the investigator.
Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.

The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.


Eligibility Criteria:
Inclusion Criteria:

* All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
* Between 18 and 90 years

Exclusion Criteria:

* COPD
* Dementia
Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer

Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.

OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-99 years of age
* Presence of an endobronchial mass
* Need for flexible bronchoscopy, with endobronchial biopsies

Exclusion Criteria:

* PCO2 \> 47 mm Hg, and/or long term Oxygen therapy
* Unwillingness to undergo fiberoptic bronchoscopy
* Coagulopathy, defined as a platelets count \< 100.000/mm3, or an INR\> 1.4, or known clinical bleeding disorder
* Therapy with anticoagulant, including Coumadin and Clopidogrel
* Renal dysfunction, defined as a Creatinine \> 2 mg/dl
* Life-threatening arrhythmias, or history of myocardial infarction within 6 months
* Cerebrovascular Accident within the preceding 6 months
* Facial abnormality preventing safe introduction of the bronchoscope
* Uncontrolled hypertension
* Active liver disease
* Pregnancy or Breastfeeding
* Prisoners
* Inability to give informed consent
Back Beliefs Among the General Population

In the current study we aim to evaluate the effects of a short educational video on improving the belief that "the back is fragile and needs to be protected" among the German speaking Swiss general population. We hypothesize that a short video education program can positively change the assessed back belief among the German speaking general population of Switzerland.

To evaluate the outcomes, we will use the 10-item version of the Back Pain Attitude Questionnaire (Back-PAQ). The primary outcome is the second question of the Back-PAQ-10 ("You could injure your back if you are not careful"). The secondary outcome of this study is the total score of the Back-PAQ-10.

The design of the present study is a two-group randomized controlled trial, with one intervention and one control group in a 1:1 allocation.

This study will be conducted in collaboration with HESAV (Haute Ecole de Sante Vaud). The research group at the HESAV has developed an educational website in 2020, called "www.infomaldedos.ch". The website aims to educate people on low back pain, and common unhelpful beliefs about the back - primarily targeting the belief about the fragility of the back and the need for its protection - are addressed. In the current study we are going to translate the above-mentioned website to the German language. Furthermore, we are going to assess the quality and applicability of a short video intervention among the general population, using one of the videos from the website.

Participants will be recruited through social media and emails. A link will be created to the questionnaire and the educational video with LimeSurvey. A 'randomizer' built-in function will be used to blindly split people into intervention or control group. The link will be spread on social media platforms and through email. To induce a snowball sampling method, all participants will be asked to send the link further.

The length of the video intervention is 3 minutes. In the video, health care professionals, such as a psychologist, a medical doctor, a professor, and physiotherapist interviewed by a scientist explains the burden of LBP, how unhelpful beliefs affect treatment outcome, difficulties in the management of LBP and the optimal way of treating LBP. The scientist then inquires a representative patient about their own experiences of the management of LBP. At the end of the video the scientist encourages people to exercise despite LBP by performing various movements.

The control group will receive a neutral video about the back, selected from YouTube.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years

Exclusion Criteria:

* Professionals and students with prior knowledge on the topic of interest such as physiotherapists, osteopaths, and chiropractors.
Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.

The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years of age
* BMI: 18-35 kg/m2
* Willingness to consume study foods.
* Willing to comply with study protocol.
* Consistent diet and activity patterns for 4 weeks
* Weight stable (≤5 kg change over the last 3 months)
* Non-smoker \>1 year or more

Exclusion Criteria:

* Allergies to foods provided in the study
* Diabetes
* Gastrointestinal disease and/or bariatric surgery
* Uncontrolled hypertension and blood pressure ≥ 180/110
* Illicit drug use
* Recent consumption of antibiotics
* Recent start of medications that affect metabolism or appetite.
* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
* Pregnant or lactating individuals
* Taste or smell disorders