cyrilzakka/clinical-trials huggingface dataset:
Use of a DeskCycle to Reduce Sedentary Behavior During the Workday

The purpose of this research was to evaluate the effectiveness of a DeskCycle intervention in reducing sedentary behavior by increasing the time spent participating in light to moderate physical activity in a randomly selected group of desk job employees at Kent State University main campus. The study also assessed the feasibility of using the DeskCycle in the working environment, as well as the effect on weight and mood. The primary outcome of interest was the 'mean minutes of light to moderate physical activity'. Secondary outcomes include weight, mood score, and feasibility of using the DeskCycle. The study was a randomized controlled trial (RCT) with a cross-over design where differences between the intervention and control group were evaluated over an eight-week period, after which there was a switch and the DeskCycles were given to the control group to use for the eight-week period that followed. The allocation during the first eight-week period intervention will be done through random process.


Eligibility Criteria:
Inclusion Criteria:

* females 18 years and above
* full-time Kent State university administrative employees at the Kent main campus
* sedentary for 75% of their workday
* height under 5'10"
* desk height of at least 27"

Exclusion Criteria:

* any uncontrolled cardiovascular diseases
* back, knee or other joint pains
Thoracolumbar Junction

Several studies have investigated the mechanical behavior of the thoracolumbar spine. However, an accurate reference for normal functional local alignment and segmental motion at the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional cohort study with a balanced distribution of age and sex of healthy subjects to examine the normal alignment and segmental motion at the thoracolumbar junction using dynamic plain radiography. This study aimed to provide data that can be used when planning surgery or performing rehabilitation in pathological situations.


Eligibility Criteria:
Inclusion Criteria:

* A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints were included if they successfully met the study's exclusion criteria

Exclusion Criteria:

* (1) coronal deformity (Cobb angle \> 10°); (2) a history of prior spine surgery; (3) a history of hip or knee arthroplasty or any other realignment surgery of the lower extremities (osteotomy, trauma, etc.); (4) complaints of back or neck pain that resulted in missed work, affected daily living activities, participation in recreational activities or required narcotic pain medication; (5) degenerative or pathologic conditions of the spine that necessitated physician intervention (i.e., physician appointment or epidural steroid injections); (6) non-ambulatory patients; (7) a history of neuromuscular disorders, inflammatory arthritis, or congenital anomalies; and (8) pregnancy
A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects

To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old
2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
4. Subject who agree not to provide sperm
5. Subject who voluntarily agree to participate in this study

Exclusion Criteria:

1. Any medical history that may affect drug absorption, distribution, metabolism and excretion
2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit
5. Any clinically significant active chronic disease
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)


Eligibility Criteria:
Inclusion criteria:

* Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
* Age 18 to 50 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure \< 90 mmHg and \>= 140 mmHg at screening
* Repeated measurement of diastolic blood pressure \< 55 and \>= 90 mmHg at screening
* Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Aerobic Interval and Moderate Continuous Exercise Training on Ventricular Functions

Hypoxic exposure increases right ventricular (RV) afterload by triggering pulmonary hypertension, with consequent effects on the structure and function of the RV. Improved myocardial contractility is a critical circulatory adaptation to exercise training. However, the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet been identified. This study investigated how high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) influence right cardiac mechanics during hypoxic exercise (HE).

Hypoxic exposure increases right ventricular (RV) afterload by triggering pulmonary hypertension, with consequent effects on the structure and function of the RV. Improved myocardial contractility is a critical circulatory adaptation to exercise training. However, the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet been identified. This study investigated how high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) influence right cardiac mechanics during hypoxic exercise (HE).

The young and healthy sedentary males were randomly selected to engage in either HIIT (3-min intervals at 40% and 80% of VO2 oxygen uptake reserve) or MICT (sustained 60% of VO2 oxygen uptake reserve) for 30 min/day and 5 days/week for 6 weeks or were included in a control group (CTL) that did not engage in any exercise. Right cardiac mechanics during semiupright bicycle exercise tests under hypoxic conditions (i.e., 50 watts under 12% FiO2 for 3 min) were measured using two-dimensional speckle-tracking echocardiography. The primary outcome was the change in right cardiac mechanics during semiupright bicycle exercise under hypoxic conditions (i.e., 50 watts under 12% FiO2 for 3 min) as measured by two-dimensional speckle tracking echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration \< 20 min).

Exclusion Criteria:

* Exposed to high altitudes (\> 3000 m) for at least 1 year.
* Smoker
* Taking medications or vitamins
* Having any cardiopulmonary/hematological risk.
Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

The goal of this pilot randomized controlled trial with economic evaluation is to evaluate the viability of Pilates in the prevention of musculoskeletal complaints, throughout the entire gestational period, in pregnant women. The main question it aims to answer is if it is feasible to perform exercises during the entire gestational period to prevent musculoskeletal disorders. Participants will be assessed primarily for acceptability, suitability, feasibility, and fidelity, and secondarily for the occurrence of musculoskeletal complaint and the number of days from randomization on which this musculoskeletal complaint occurred, type of delivery and costs. Then, participants will be randomized into two groups: the usual care group, which will receive an educational booklet with information about the usual care during pregnancy, and the Pilates group, which will receive the same educational booklet and will participate in a specific Pilates exercise program for the gestational period, twice a week, throughout the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women of usual risk in the 12th gestational week (gestational age determined by the date of the last menstruation or by the ultrasound examination)
* with medical clearance to practice physical activity

Exclusion Criteria:

* practice of other physical activity during pregnancy
* any medical contraindications, such as diabetes and hypertension
Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.


Eligibility Criteria:
Inclusion Criteria:

* History of biopsy proven celiac disease
* Adherence to a gluten-free diet (established patients only)
* TG2 negative (established patients only)
* TG2 positive (newly diagnosed patients only)
* Signed informed consent

Exclusion Criteria:

* History of IgE-mediated reactions to gluten
* Significant laboratory abnormalities
* History of untreated or GI disease
* Positive pregnancy test
* Any medical condition which could adversely affect study participation
A Performance Evaluation of the Enlite 3 Sensor

The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor performance in arm in subjects age 14 - 75 years.

The study is a multi-center, randomized, prospective single-sample correlational design without controls.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 14 - 75 years of age at time of screening.
2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff
4. Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual.
2. Subject has any unresolved adverse skin condition in the area of Enlite 3 Sensors or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator.
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months.
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
10. Subject has a history of a seizure disorder.
11. Subject has central nervous system or cardiac disorder resulting in syncope.
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease.
13. Subject has a hematocrit(Hct) lower than the normal reference range.
14. Subject has a history of adrenal insufficiency
CardioInsight 3 - LBBB

Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation The purpose of the Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing is to study the acute effect on the heart function and conduction abnormality of His and left bundle pacing in conventional CRT candidate. During CRT implantation, Hisbundle lead and Left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. The pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 or above) of both sexes
* Candidate for CRT therapy according to international guidelines.7
* Informed consent by the patient
* Already received stable dose of guideline directed medical therapy for at least 3 months

Exclusion Criteria:

* Pregnant
* Participating in another study
Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A healthy Male adults aged 19-50 years

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* Hypersensitivity to ingredient of IP and other medication, food.
* Participation in any other study within 3months.
* History of whole blood donation within 2months and Apheresis 1month.
Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries

An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD.

Cardiovascular complications are the major cause of death in end-stage renal disease (ESRD) patients undergoing chronic haemodialysis (HD).1 During haemodialysis (HD) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 Adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (NO) bioactivity and enhanced formation of oxygen-derived free radicals.7 Given that endothelial dysfunction is at least in part reversible, the assessment of altered NO availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in HD.8 Nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 The rates of NO consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will NO produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 However, the rate of NO scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 This mechanism is believed to be important in various conditions of health and disease.14-16 In ESRD intravascular hemolysis during HD has been described.17-19

Eligibility Criteria:
Inclusion Criteria:

* patients older 21 years dependent on HD for more than 6 months

Exclusion Criteria:

* known HD associated hypotension intake of nitrate
Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Voluntarily sign informed consent.
* The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor.
* Need to be treated with radiotherapy.
* ECOG PS Score: 0/1.

Exclusion Criteria:

* There are contraindications to radiotherapy.
* Combined with other tumors.
* Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), and mental illness.
* At the investigator's discretion, those who was not considered to be suitable for participation in the study.
Sex and Exercise-mode Differences in Post Exercise Blood Pressure and Heart Rate Variability Responses During Workday

The present study compared the acute effects of Sex and exercise mode on subsequent blood pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults. All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym and a seated control session.

Resting blood pressure and heart rate variability are simple and non-invasive methods to evaluate cardiovascular risk after different exercise sessions. Thus, exercise can reduce these risk factors in the short and long term, but these responses can be different between sex in different exercise sessions.

Eligibility Criteria:
Inclusion Criteria:

* Able to practice aerobic and resistance exercise at moderate intensity;
* Men and women;
* Normotensive, pre-hypertensive or hypertensive stage 1.

Exclusion Criteria:

* Renal pathologies;
* Using beta blockers;
* History of stroke or acute myocardial infarction;
* Smokers.
A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

This trial was conducted at about 50 sites in Europe and has been clinically completed. Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. Patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. After a 2-week run-in phase patients were randomly assigned to one of three treatment arms. All patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. At the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. The change in pain was measured daily as well as interference of pain with sleep and general activity.


Eligibility Criteria:
Inclusion Criteria:

* Painful distal diabetic neuropathy

Exclusion Criteria:

* Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years
Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy

Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity with body mass index more than 40 or 35 with at least one comorbidity

Exclusion Criteria:

* extreme of age less than 18 or over 65 years contraindications to laparoscopy
Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis

The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; age between 18 and 75 years.
* Patient with symptomatic STT OA.
* Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
* Patient with a QuickDash score \> 33 points (converted to 50%).
* Patient with wrist pain (VAS) in front of the STT joint at rest \> 4/10.
* Patient who received the study information and provided consent.
* Member or beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman; woman without effective contraception.
* Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
* Patient with signs of neuropathy with functional disorders such as hyperesthesia.
* Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
* Person confined by a judicial or administrative decision.
* Adult subjected to legal protection measures or unable to provide his/her consent.