cyrilzakka/clinical-trials huggingface dataset:
Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients

This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
* Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
* Body weight less than or equal to 100.0 kg
* Body Mass Index (BMI) less than or equal to 30.0 kg/m\^2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products (including rFVIIa)
* Previous participation in this trial defined as administration of trial product
* The receipt of any investigational product within 30 days prior to trial start (screening)
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
* Any surgery within 30 days prior to screening
* Planned surgery within the trial period
* Platelet count below 50,000 platelets/mcL (based on medical records within the last 1 month or laboratory results at screening)
* Prothrombin time (PT) above 4 times Upper limit of normal (ULN) or International normalised ratio (INR) greater than 1.7
* Hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician)
* Renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening)
* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
* Any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome
* Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
BerryCare: A Community Engagement Program

BerryCare teaches people about the health benefits of blackberries, how to harvest and maintain blackberry bushes and then assesses changes in knowledge and behaviors associated with blackberries and physical measurements.

BerryCare seeks to teach community members how to grow thornless, erect blackberry brambles and to healthily consume fresh blackberries using Plate It Up Kentucky Proud recipes. Horticulture, nutrition, and extension experts are working together to design a blackberry-growing program that engages citizens and their community in each step of the process, from planting to harvesting berries. The lessons will be delivered by experts in their respective field, with accompanying extension publications and supplemental materials provided for replication of the curriculum in other counties.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Physically incapacitated
* Mentally incapacitated
Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device

Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Novice and expert Invasive bedside procedure (IBP) teachers from Pulmonary Critical Care Medicine and Anesthesia-Critical Care at Mayo Clinic Rochester
* Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences
* Novice teachers will include those that have performed less than 50 CVCs
* Medical student or resident

Exclusion Criteria:

* \<25% FTE in the ICU
Investigation of The Effect of "Instrument-Assisted Soft Tissue Mobilization" in Individuals With Lumbar Disc Herniation

Instrument-assisted soft tissue mobilization is an instrument-assisted soft tissue mobilization technique. It consists of stainless steel instrument designed to adapt to various tissues/shapes/curves of the body. The instruments were developed as an alternative to transverse friction massage. Stainless steel acts a bit like a diaposon when it comes into contact with fibrotic tissue. A resonance or reverberation in the instrument is created upon contact and transmitted through the instrument to the hands of the clinician. The application of heavy pressure (compared to light or medium pressure) using instruments has been proven to promote a greater fibroblastic response.

Instrument-assisted soft tissue mobilization is not used without insulation. It is imperative to use movement and strengthening in combination with soft tissue mobilization to promote tissue adaptation and remodeling. Mechanical loading has been shown to affect chondrocyte alignment and fibroblast activity with increased proteoglycan and collagen synthesis. The aim of this study was to investigate the effects of the IASTM technique on individuals of different ages diagnosed with LDH.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals have been diagnosed with LDH,
2. Their pain is 3 and above according to the Visual Analog Scale (VAS),
3. They are between the ages of 20-60,
4. Their clinical status is stable,
5. They are fully cooperative,
6. They do not have cognitive, cognitive and mental problems and they can express themselves,
7. They voluntarily agree to participate in the study.

Exclusion Criteria:

1. Individuals have psychological disorders, mental disorders, cancer and severe depression,
2. Primary or metastatic spinal malignancy,
3. Have been diagnosed with advanced osteoporosis,
4. Have recently undergone surgical intervention or acute infection,
5. Cannot or do not want to perform tests or treatment exercises,
6. Want to leave voluntarily.
A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)

This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD). The study will review the clinical data previously collected during February 2007 to March 2020 of approximately 724 participants who have had treatment with adalimumab, infliximab, golimumab, or vedolizumab in Taiwan.

This is a non-interventional, retrospective study in newly diagnosed IBD participants (UC or CD) treated with biologics.

The study will assess IBD relapse, effectiveness, and safety of biologic treatments in IBD participants. The study will enroll approximately 724 participants. The data will be collected from the electronic medical record (EMR) database of selected medical centers in Taiwan. IBD Participants who were evaluated and treated at the participating sites between 01 February 2007 to 31 March 2020 will be included. Participants will be assigned to the following two observational cohorts based on pathological diagnosis:

* Cohort 1: Participants With Biologics Discontinuation
* Cohort 2: Participants Treated With Biologics

This multi-center trial will be conducted in Taiwan. The overall duration of the study will be approximately 15 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed during February 2008 to March 2020 (or per local institutional review board \[IRB\] permitted date).

   * CD (International Classification of Diseases, Ninth Revision, Clinical Modification \[ICD-9-CM\]: 555.X or International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\]: K50.XX, K50.XXX)
   * UC (ICD-9-CM: 556.X or ICD-10-CM: K51.XX, K51.XXX).
2. Had received any dose of biologics for IBD treatment, including vedolizumab adalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per local IRB permitted date).

Exclusion Criteria:

1. Participants with any suspected diagnosis of CD or UC within one year before the initial date of confirmed IBD diagnosis will be excluded.
Norwegian Adenomyosis Study I

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.

Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.

Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.

Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.

The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.

NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis

Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.

We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged 30 - 50 years old
* scheduled for vaginal, abdominal or laparoscopic total hysterectomy
* one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia
* junction zone definable

Exclusion Criteria:

* postmenopausal women,
* pregnancy
* gynecological cancer
* GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
* junctional zone not identifiable
Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults

The purpose of this project is to investigate the effects of breaking up prolonged sitting on postprandial metabolic responses, gut hormones secretion and energy balance in sedentary overweight and obese adults.

Two trials are included in this project - Prolonged sitting and Breaking sitting.

In the Prolonged sitting trial, after consuming breakfast, participants sat on a chair for 180 min. After 180 min, lunch was provided. After finishing lunch, participants sat on a chair for another 120 min. In the Breaking sitting trial, after consuming breakfast, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, lunch was provided. After finishing lunch, participants continued 2 min of walking every 20 min for the following 120 min. Blood samples were collected in a regular pattern throughout the trials. Energy balance (e.g., energy intake and spontaneous physical activity) was assessed using food diary and an accelerometer until midnight in the trial days once participants left laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Physical inactive males and females
* Aged between 20 and 45 years
* Overweight and obese healthy adults (waist circumference greater than 90 cm for males and 80 cm for females)
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker
* Able to walk comfortably on a treadmill

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Waist circumference \< 90 cm for male and \< 80 cm for female
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function
* Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)
Hospital-level Variation in the Management of Blood Pressure and Low-density Lipoprotein in the Outpatient Hypertensives in China-a Cross Sectional Study

To investigate the proportion, medication use and control rate of metabolic abnormalities such as dyslipidemia in outpatients with hypertension in different levels of hospitals in China. To investigate the gap between guidelines and clinical practices, and analyze the cause. we also set up a continuing medical education program to narrow the gap and the effect of the program will be estimated.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
2. Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
3. Voluntary participation.

Exclusion Criteria:

1. Patients aged\< 18 years old.
2. Patients without a definite diagnosis of hypertension（for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension）.
3. Patients with a definite diagnosis of secondary hypertension.
4. Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
5. Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
6. Patients diagnosed with mental abnormalities who are unable to complete the questionnaire.
7. Patients have once participated in this research during this study cycle（to avoid repeated participation）.
Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin

The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.


Eligibility Criteria:
Inclusion Criteria:

* Patient with missing anterior mandibular teeth
* horizontal bone width \< 5 mm
* Adequate zone of keratinized tissue

Exclusion Criteria:

* Presence of infection or periapical lesions in adjacent teeth
* Medically compromised patients with a condition that affect the procedure
* Insufficient inter-arch distance
* Bruxism or clenching
* Alcoholism
* Smokers
Retrospective Modulus ALIF Study

The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.

The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:

1. Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and
2. Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and
3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available

Eligibility Criteria:
Inclusion Criteria:

1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
2. Male or female patients who are ≥18 years of age at the time of surgery
3. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
4. Treated with ALIF procedure with the Modulus ALIF System at:

   * One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
   * Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve) or sagittal deformity
5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:

   * 1-2 levels treated for DDD, and
   * 3 or 4 interfixated screws placed, and
   * Implant lordosis is ≤20°

Exclusion Criteria:

1. Patient was a prisoner at the time of Modulus ALIF treatment
2. Patient was participating in another clinical study during treatment that would confound study data
Dairy and Vegan Cheese: Effect on Satiety and Blood Glucose

The project will consist of two studies. One study will explore the satiating properties of dairy cheese and its dairy-free substitute when consumed ad libidum, and another study will investigate their effects on postprandial glycemia. Both studies will involve healthy young adults. The secondary outcomes of these studies will be food sensory characteristics, diet-induced thermogenesis, subjective feeling of fatigue and energy, gastrointestinal comfort level, and food intake. The proposed project results will help to better understand the health properties of the cheese and its dairy-free substitute.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults

Exclusion Criteria:

* Breakfast skipper
* Smoker (including e-cigarettes) / cannabis consumer
* Be underweight, overweight or obese
* Have chronic diseases, including diabetes
* Taking certain medication
* Have lactose intolerance, food allergies or gastrointestinal disorders (e.g., irritable bowel syndrome, or others).
Prevention of Atrial Fibrillation Following Esophagectomy

The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:

Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.

Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.

Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Males or females over the age of 40
* Scheduled to undergo esophagectomy

Exclusion Criteria:

* History of atrial fibrillation
* Prior severe side effects from amiodarone
* Elevated liver enzymes \>3 times the upper limit of normal (UNL)
* Corrected QT interval \> 450 ms
* Receiving class Ia or class III antiarrhythmics