cyrilzakka/clinical-trials huggingface dataset:
Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers

Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg tablets of linagliptin


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
* Age 18 to 55 years (inclusive)
* BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Alcohol abuse ( average consumption of more than 20 g/day in females and 30 g/day in males)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site

For female subjects only:

* Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
* No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
* Lactation
Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments

The goal of this clinical trial is to test a 6-month, twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are:

1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week.
2. Are their changes at 3-months and 6-months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve).

Participants will exercise twice a week in-person with a coach or at a distance location with coaching support for six months.

In person Exercise Group:

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist). The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will attend times per week for six months. Coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion. Participants will be able to continuously attend as long as they are attending regularly.

Distance Exercise Group:

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist) which will occur in person. The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will exercise on their own 2 x a week for 6 months.Coaches will prescribe an exercise program that can be performed at a local fitness facility or at home and it will be shared through a coaching software. Participants will log their exercises either in the coaching software or in paper formats, have weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions. Participants who do not log any activity and miss weekly check-ins will have follow up from fitness center coaches.

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of mild-moderate cognitive impairment
* medically cleared for exercise
* able to follow 2-step commands Exclusion criteria are significant pain with movement (\>5/10)

Exclusion Criteria:

* significant pain with movement (\>5/10)
* severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgement).
Effect of the Diaphragm Release Technique on Sleep Duration and Quality

Even in healthy individuals, there may be tensions in the diaphragm muscle due to factors such as wrong posture, wrong breathing pattern, sedentary lifestyle, and it cannot fully fulfill its function. As a result of this tension in the diaphragm muscle, the breathing pattern deteriorates and sleep quality decreases. The aim of this study is to examine the effect of diaphragm release technique on sleep duration and sleep quality in healthy individuals. In this study, sleep quality of individuals will be evaluated with Pittsburgh Sleep Quality Index (PUKI), sleep duration, heart rate and step count with Fitbit® Inspire 2. 32 individuals living in Tokat will be included in the study. After obtaining the sociodemographic information of the individuals, the average of sleep duration, heart rate and step counts will be recorded for 3 days with the Fitbit® Inspire 2 wearable technology to be provided within the scope of the project. Sleep quality will be recorded with PUKI. The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between. After the applications are finished, sleep time, heart rate and step counts will be recorded for 3 days with Fitbit® Inspire 2 wearable technology.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.

Exclusion Criteria:

* Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.
Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects

The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the researchers will investigate individuals with and without intact nervous supply.

GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of GLP-1 on the food intake, gastric emptying (GE) and appetite.

Eligibility Criteria:
Inclusion Criteria:

* truncal vagotomy
* normal hemoglobin
* informed consent
* Age, gender and weight matched controls
* normal hemoglobin
* informed consent

Exclusion Criteria:

* type 1 diabetes mellitus or type 2 diabetes mellitus
* body mass index \> 30 kg/m2
* inflammatory bowel disease
* intestinal resection
* nephropathy (serum creatinine \> 150 µM and/or albuminuria)
* liver disease (ALAT and/or ASAT \> 2 x normal value)
* treatment with medicine which cannot be paused for 12 hours
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older at the time of screening
* Provide written informed consent and are able to comply with all study requirements
* Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
* Have a negative pregnancy test result for women of childbearing potential at Baseline
* Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

* Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
* Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
* Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee

The purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee.

Osteoarthritis (OA) makes up a large proportion of the disability and economic costs in the U.S. The knee is the most common site of OA and is a common cause of disability and the leading indication of total knee replacement in the elderly. There are presently no curative therapies for OA. Recently, increased attention has focused on the use of complementary and alternative medicine (CAM) therapies, such as acupuncture, especially for patients who have failed to respond to more standard therapy. Little is known of the long-term health services utilization and outcomes of patients with knee OA. This study will evaluate the cost effectiveness and overall outcomes of acupuncture for OA treatment.

Participants in this study will be randomly assigned to receive either acupuncture or placebo. Surveys and questionnaires will be used to assess participants. Data will be collected on the short- and long-term utilization of health services as well as on pain and physical function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis (OA)
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Participant has provided informed consent
* History of migraine (with or without aura) for ≥ 12 months before screening
* ≥ 4 migraine days per month on average across the 3 months prior to screening
* Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
* Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion Criteria:

* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headaches
* Evidence of substance-related disorders
* Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
* No therapeutic response with \> 3 migraine preventive medication categories
* Used a prohibited medication, device, or procedure
* Other clinically significant disorder, condition, or disease
Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management

This study aims to develop a wearable electrocardiograph monitoring device and smartphone application in perioperative pain management, also to evaluate relationship between postoperative pain and heart rate variability.

This study is a prospective observational cohort study implementing wearable electrocardiogram (ECG) monitor device and smartphone application in perioperative pain management. Patients undergoing major abdominal surgical procedures will be recruited to wear a ECG monitor device from the day before surgery until 1-3days after surgery. Patients will report their condition of pain twice daily on the corresponding smartphone application based on a structured and visualized pain report module. Patients will receive a telephone follow-up 30/60/90/365 days after surgery for assessment of postoperative chronic pain. A pilot study will be conducted to evaluate acceptability, safety and feasibility of the device and application using system usability scale and comprehensive product quality assessment. Further study will be conducted to evaluate the relationship between postoperative acute and chronic pain and heart rate variability (HRV) acquired from ECG device.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing major abdominal surgical procedures;
* 18-65 years old;
* ASA classification: I-IV
* able to read and understand how to use the App after instruction；
* written informed consent obtained.

Exclusion Criteria:

* current participation in other mobile device research or perioperative pain research;
* inability to use the device;
* inability to obtain consent.
Maternal Positioning and Occipitoposterior Fetal Position

The aim of the study is to evaluate the efficacy of a specific maternal position to correct fetal position in occipito-posterior during the labor.

The investigators hypothesize that the maternal position described by the Dr de Gasquet facilitate the rotation in occipito-anterior during the labor.

The calculated sample size is 438 participants (219 in each group)

Randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* singleton
* primiparous and multiparous
* Term ≥ 37 weeks
* Labor in dilatation phase (cervix effaced, permeable finger 2 to 9 cm)
* Diagnosis of occipitoposterior variety confirmed by ultrasound

Exclusion Criteria:

* Maternal age below 18 years old
* Misunderstanding the French Language
* Full dilatation of the cervix
* Posture evaluated already adopted by the woman during labor
Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency

Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).

Iron Deficiency (ID) is a comorbidity in heart failure (HF) patients with high prevalence and severe clinical consequences. Multiple studies have shown that ID in HF patients impairs exercise capacity, quality of life and outcome. It is currently unknown whether these detrimental consequences of ID are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. This study was designed to quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF.

Eligibility Criteria:
Inclusion Criteria:

For HFrEF patients:

* Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
* Stable, evidence-based medical therapy for HF;
* LVEF \<40% measured \<5 year prior to inclusion;
* NYHA class II - III (symptomatic HF) at moment of inclusion;

For HFpEF patients:

* Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
* LVEF \>40% and one of the following parameters, measured \<5 year prior to inclusion;
* Left atrial volume index (LAVI) \>34 mL/m2 or
* left ventricular mass index ≥115 g/m2 (for males) or ≥95 g/m2 (for females) or
* E/e' ≥13 or
* mean e' (septal and lateral) \<9 cm/s
* NYHA class II - III (symptomatic HF) at moment of inclusion;
* Serum NT-proBNP ≥125 pg/mL when in sinus rhythm; \>300 pg/mL when in atrial fibrillation.

Additional inclusion criterion for subjects with ID:

- Iron deficiency, defined as TSAT \<20%.

Exclusion Criteria:

* Age \<18 years;
* Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical disabilities, claustrophobia);
* The presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink);
* History of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion \<3 months prior to study enrolment;
* Moderate anaemia, defined as Hb \<7 mmol/L for both men and women;
* Oral iron therapy \>100 mg/day \<4 weeks prior to study enrolment;
* Unable to understand study procedures;
* Unable or unwilling to provide informed consent.
A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values

In this randomised controlled trial of patients with stable angina and documented intermediate coronary disease with indeterminate or "grey-zone" Fractional Flow Reserve (FFR) we will randomise patients to either optimal medical therapy alone versus optimal medical therapy with PCI and they will be followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.

Pressure derived fractional flow reserve (FFR) is recognised as being the gold standard method of assessing the physiological significance of angiographically intermediate lesions. A grey-zone exists between the originally validated cut-off for ischemia of \<0.75 and the conventionally adopted cut- off of ≤0.80. Pilot data from our centre has suggested that only 1 in 3 coronary arteries with grey-zone FFR values demonstrate myocardial perfusion defects on stress cardiac MRI and others have suggested that the clinical outcomes in patients with grey-zone FFR are favorable with medical therapy alone. As such, stenting all lesions with grey-zone FFR (as currently recommended) may represent over-treatment and could attenuate the overall benefit of an FFR strategy. In addition to this there are flow derived resistance indices of stenosis severity that have superior diagnostic accuracy and may be helpful in correctly classifying patients with grey-zone FFR. In this study we will a comprehensive analysis of lesions with grey-zone FFR values (0.75-0.82 inclusive) using invasive hyperemic pressure, flow and resistance derived indices of severity with quantitative and qualitative 3T perfusion MRI to enable identification of the best invasive predictors of true perfusion defects on 3T cardiac MRI. Patients will be randomised to optimal medical therapy alone versus optimal medical therapy with PCI and followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>18 years
2. 30-80% Diameter Stenosis on QCA
3. Stable angina
4. Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
5. Able to provide informed consent

Exclusion Criteria:

1. STEMI within 5 days
2. Tortuous vessels which would render pressure wire studies difficult or impossible
3. Heavily calcified vessels which would render pressure wire studies difficult or impossible
4. Unstable symptoms requiring definitive interventional management
5. Severe claustrophobia
6. Age \>90 years
7. Life expectancy \<1 year
8. Estimated Glomerular Filtration Rate \<30 mls/min/1.73m2
9. Inability to undergo MRI scanning due to metallic implant or incompatible permanent pacemaker
10. Severe asthma or inability to safely receive an adenosine infusion
11. Left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.
Safety Study of Erythropoietin (EPO) in Parkinson's Disease

The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.

After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. At present, the treatment of PD with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear.

For this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO).

Positive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Hohen and Yahr´s Scale between I and III
* One or more years of evolution of PD,
* Good response to levodopa (more that 30 % of change)valued in motor UPDRS
* An acceptable general health status,

Exclusion Criteria:

* Chronic psychiatric or other neurological diseases.
* Previous polyglobulin
* Hematocryte, same or inferior to 50