cyrilzakka/clinical-trials huggingface dataset:
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice

Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease.

In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting.

The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

* Participants with IBD

This multi-center study will be conducted in Austria at specialized gastroenterology centers. The overall duration of the study will be 24 months. Data will be collected at baseline, at 3 months after induction, and every 6 months after induction, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)

The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)
A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM). The study will also evaluate if LY3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. The study will last approximately 16 weeks excluding screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin
* Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Are males or females not of childbearing potential

Exclusion Criteria:

* Have acute proliferative retinopathy requiring active treatment within 3 months of screening
* Have been treated with dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months
* Have received systemic or inhaled glucocorticoid therapy
* Women of childbearing potential
* Are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention
Chlorhexidine Bathing Effect on Clostridium Difficile Rates

Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding their high mortality, one recent study attributes a near quadrupling of hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to help reduce the incidence of highly virulent pathogens and hospital acquired infections. Further, several studies show a favorable effect of reducing the incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have focused on the effects of these baths on general medical/surgical wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on the general medical/surgical wards who are exposed to antibiotics for a suspected or confirmed infection.


Eligibility Criteria:
Inclusion Criteria:

* Prescription of antibiotics for suspected or confirmed infection.
* Admitted to the 2600 General/Medical ward at Delnor Hospital.

Exclusion Criteria:

* Antibiotics only for surgical prophylaxis
* Not mentally capable
* Cannot provide consent in English
* Pregnant
* Documented chlorhexidine allergy
* Patient is a prisoner
* Health system employee
A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects

The objectives of this study were to evaluate the safety and tolerability of lucerastat, and to determine its pharmacokinetic profile as single oral doses at different strengths.

The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Male subjects aged from 18 to 45 years at screening.
* Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
* Serious adverse reaction or hypersensitivity to any drug.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Turkish Validity and Reliability of the UW Concerns About Pain Scale

Brief Summary:

The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns About Pain Scale'' developed by Dr. Amtmann.

Chronic pain is a common condition, affecting an estimated 20% of people worldwide. The biopsychosocial model of chronic pain is the most current accepted approach to understanding the complexity of pain and disability. One of the most important psychosocial factors in this approach is pain-related self-efficacy, which is defined as the individual's confidence in their ability to tolerate pain and participate in daily activities despite pain. The aim of this study is to determine the Turkish version, validity, and reliability of ''UW Concerns About Pain Scale''. 60 people with chronic low back pain will include in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. For construct validity, the correlation coefficient will be used to determine the agreement between the Turkish version of Pain catastrophizing scale and, Turkish version of "Fear Avoidance Beliefs Questionnaire" and The ''UW Concerns About Pain Scale''.

Eligibility Criteria:
Inclusion Criteria:

1. To be between 18-65 years old
2. Having a complaint of low back pain for at least 6 months
3. Low back pain severity to be 3 points or above according to the Numerical Graded Pain Scale.

Exclusion Criteria:

1. Using antidepressant-derived drugs
2. Having a history of spinal surgery
Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and

A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.

Eligibility Criteria:
Inclusion Criteria:

1. age of 18\~70, BMI ≥ 18 kg/m2
2. Female patients must avoid pregnancy
3. Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
4. Chest X-ray shows inflammatory exudation or infiltration image.
5. Patients who used antibacterial agents (excluding quinolones) within 72 hours before
6. The patient's disease condition permits oral administration

Exclusion Criteria:

1. Patients who have any of bronchiectasis and pulmonary disease.
2. Hospitalized within 14 days before enrollment
3. Have a history of allergy to any quinolone or fluoroquinolone antibiotic
4. Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
5. Renal, liver insufficiency
6. Malabsorption syndrome or other gastrointestinal diseases
7. Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen
8. Steroids longterm use, the dose is at least 20mg of prednisone daily
9. Patients under critical condition.
10. Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
11. Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
12. Patients who received chemotherapy or anti-tumor therapy within 6 months
13. Alcohol abused or drugs banned
14. Patients who used quinolones within two weeks before enrollment
15. Donated more than 500ml of blood within 3 months
16. co-medication of other antibacterial agents required.
17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.
A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E

The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.

The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India. The clinical trial is not a global trial. Three administrations of ORV 116E will be co-administered with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, Haemophilus influenzae B and Hepatitis B and OPV) at 6 to 7 weeks, greater than or equal to 10 weeks and greater than or equal to 14 weeks of age. 6800 subjects will be enrolled in three sites - Delhi, Pune (Maharashtra) and Vellore (Tamil Nadu) and followed up till the age of 2 years (24 months + up to 14 days). Multiple trial sites are included to ensure greater demographic distribution to obtain evidence of cross immunity and quicker recruitment of the necessary number of subjects. The subjects to be included from these sites would be representative of the population of India.

The protocol has been reviewed by the institutional review boards of the Society for Applied Studies (New Delhi), KEM Hospital Research Centre (Pune), Christian Medical College (Vellore). Ethics clearance has also been obtained from the Department of Biotechnology, Government of India and Western Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

* At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
* Subjects aged 6 to 7 weeks at recruitment
* No plans to move in the next 24 months

Exclusion Criteria:

* Administration of rotavirus vaccine in the past
* Presence of any illness requiring hospital referral (temporary exclusion)
* Known case of immunodeficiency disease, known HIV positive
* Known case of chronic gastroenteritis disease
* Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect)
* Diarrhea on the day of enrollment (temporary exclusion)
Whole Body Vibration Training for Pelvic Floor Muscle

To study which position on the whole body vibrator machine would stimulate the pelvic floor muscles.

Urinary incontinence is a common problem due to a weak pelvic floor muscle associated with decrease quality of life. The vibration exercises have been associated with improvements of the muscle component. Due to this, some researches have proposed that this technique could be applied to weak pelvic floor. However, it is unknown which vibration trainings have the highest impact on the pelvic floor muscle and urinary sphincter, more objectives studies to validate these data are necessary.

The purpose of our research is to evaluate the activity in the urinary sphincter and the pelvic floor muscle by vibratory platform training in women.

Subjects will be recruited, criteria exclusion will be evaluated, age, and BMI will be recorded. Each subject will exercise on the vibratory platform in 3 different positions, each one with 2 different frequencies and 1 minute each position and frequency. Pelvic electromyography (EMG) will assess the activity of the urinary sphincter and pelvic floor muscle with vibratory exercise. Data will be collected during all procedures.

According to our purpose and anticipating the impact of this research extrapolating whole body vibration (WBV) training as program to improve the strength of the pelvic floor muscle elaborating a guided plan to improve clinical outcomes and quality of life of patients suffering from urinary incontinence with this new nonsurgical treatment approach to women with mild to moderate stress urinary incontinence, as well as this research allow us to increase our knowledge in urinary continence and the pelvic floor.

Eligibility Criteria:
Inclusion Criteria:

Women over 18 years of age

Exclusion Criteria:

Criteria exclusion like unhealthy condition, acute thrombosis, acute inflammations, implants, fractures, acute tendinopathies, kidney or bladder stones, gallstones, lung disease, heart disease, skin disease, hypertension, any medication or disease known to affect muscle mass or strength and pregnant will be evaluated
The Neuralert Stroke Monitor Pilot Trial

This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, integration into clinical workflow, usability and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 22 years
* Admitted to or planned admission to the Hospital of the University of Pennsylvania and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
* Considered at high risk for stroke while in the hospital based on:

  1. Interventions or procedures performed during the hospitalization including: Intracardiac surgical or endovascular procedures including valve replacement, ascending aorta or aortic arch surgical or endovascular repair, and open surgical or endovascular carotid revascularization
  2. Other CT surgery or Vascular surgery procedures in patients with high risk characteristics including: Atrial fibrillation, prior stroke/TIA, hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation, severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis, or age ≥ 80.

Exclusion Criteria:

* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Baseline asymmetric upper extremity weakness as assessed by the study team at time of enrollment, defined as an NIHSS upper extremity motor score \>0 in either arm.
* A limb amputation above the wrist in the upper extremities
* Unwilling to provide informed consent and no legally authorized representative willing to provide informed consent if the patient is unable
Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)

The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy female \> 40 years of age with a body mass index (BMI) ≤ 40;
2. Has undergone menopause defined as any of the following:

   At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy);
3. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week

Exclusion Criteria:

1. Resting systolic blood pressure (SBP) \<110 mmHg, resting diastolic blood pressure (DBP) \<50 mm Hg, or a resting heart rate (HR) \<60 beats per minute while awake;
2. Subjects with pre-existing orthostatic hypotension at Screening;
3. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
4. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications
Inflammatory Bowel Disease (IBD) Research Registry

Patients seen at the Center for Inflammatory Bowel Disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their Inflammatory Bowel Disease to be placed in Center's Research Registry for the purpose of facilitating retrospective research studies directed at Inflammatory Bowel Disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving Inflammatory Bowel Disease.

Information obtained from the Inflammatory Bowel Disease Registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of IBD and may permit the development of better therapies and the potential for preventive therapies.


Eligibility Criteria:
Inclusion Criteria:

All patients age 18 and above seeking medical care at the Center for Inflammatory Bowel Diseases Clinic at UPMC

Exclusion Criteria:

N/A
Patient-centered Communication About Healthy Weight in Early Breast Cancer

Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.

The overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "Patient-Center Communication about Healthy Weigh in clinical practice

Primary Objective:

1. Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups

   Secondary Objective
2. Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria for Breast Cancer Cohort:

* Age 21 or older
* Diagnosed with early breast cancer, Stages I-III
* Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years
* Body mass Index of equal or greater than 30

Exclusion Criteria:

* Cannot understand and speak English

INclusion Criteria for Oncology provider cohort:

* Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN
* associated with community-based practices