cyrilzakka/clinical-trials huggingface dataset:
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.

This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.

This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria.

Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days.

Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject with diabetes mellitus type 2
2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
3. HbA1c 7.0%-9.9%, both inclusive
4. Diabetes duration of at least 24 months)

Exclusion Criteria:

1. History of diabetes mellitus type 1
2. GFR (as calculated by the Cockcroft-Gault equation) \< 60 ml/min at Screening
3. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.

Reference for published version of the complete study:

Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. \[Epub ahead of print\]

Eligibility Criteria:
Inclusion Criteria:

* Adult patients needing new complete dentures
* Mentally receptiveness
* Absence of dysfunctional disorders of the masticatory system
* Normal volume and resilience of residual edentulous ridges
* Absence of debilitating systemic diseases

Exclusion Criteria:

* Use of cardiac pacemaker
* Refusal to participate or inability to provide informed consent
Neural Enabled Prosthesis for Upper Limb Amputees

This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.

The purpose of this study is to evaluate a new prosthetic system for transradial amputees called the neural-enabled prosthetic hand (ANS-NEPH). It is intended to provide the sense of touch, grasp force and hand opening to the user by sending electrical stimulation pulses to electrodes implanted in nerve fascicles in the upper arm of the residual limb. The system uses measurements from sensors in the prosthetic hand and wireless communication to the implanted neurostimulator to adjust the pulses continuously so that the user gets sensation as tasks are performed with the prosthesis.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral transradial amputation
2. Amputation occurred 9 months ago or more
3. Functional hand contralateral to the amputation
4. Ability and willingness to use myoelectric arm (as determined by prosthetist)
5. 18 years of age or older
6. Ability to obtain transportation to the research site and the clinicians' offices
7. U.S. citizen or permanent U.S. resident
8. Signed the Informed Consent Form

Exclusion Criteria:

1. Absence of limb due to birth defect
2. Evidence of denervation of the residual limb
3. Phantom limb pain that is severe enough to impair or restrict activity
4. Any neurological condition affecting motor and/or sensory function that would interfere with use of the intact hand or residual limb (as determined by neurologist)
5. Visual impairment that would affect hand usage during experimental procedures
6. History of chronic infections
7. History of recurring ulcers or blisters on the residual limb
8. Evidence of an active infection, non-healed ulcer, recent history of a healed ulcer (\< 3 months)
9. Use of another implanted electrical device (such as a pacemaker or nerve stimulator)
10. Undergoing diathermy therapy of the residual limb
11. History of non-compliance with medical or research procedures or any condition that would limit their ability to comply with study related procedures (self-reported)
12. Self-reported emotional or psychological disorders or history of drug or alcohol abuse or addiction
13. Memory disorders or significant cognitive impairment (self-reported and/or clinical observation during consent and screening procedures)
14. Moderate to severe chronic pain
15. Pregnant or nursing
16. Self-reported sensitivity to material derived from porcine source
17. Enrolled in another investigational research study
18. Any medical or psychiatric condition not otherwise specified (such as uncontrolled high blood pressure, heart or lung disease, active infection, and serious metabolic disorders) that would expose the subject to unacceptable risk and/or limit their ability to perceive meaningful sensation from stimulation of the peripheral nerves of the residual limb.
SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias

This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.

Cardiac arrhythmias are a common clinical problem in cardiology. Often, such arrhythmias can be effectively and permanently treated through catheter ablation.

A key technology enabling the success of catheter ablation is activation mapping of cardiac arrhythmias. This refers to the construction of maps which depict the sequential activation of the cardiac chamber of interest. It is a fundamental electrophysiology technique, but at the same time, the principles behind activation map construction have not changed for decades.

In brief, the way activation maps are constructed nowadays consists of the following steps:

(i) Sequential acquisition of voltage signals throughout the cardiac chamber of interest, recording both the signal together with the location of the signal in 3D space (ii) Local activation time annotation of each of the acquired signals in relation to a so-called timing reference (iii) Depiction of the annotated activation time graphically as a so-called activation map, through which the mechanism of the arrhythmia can be understood and an appropriate ablation target chosen

Following assignment of the LAT to each individual signal, the map is complete and can be used to discern the arrhythmia circuit to choose an appropriate ablation target.

The objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinically indicated EP mapping and ablation procedures.

Specific objectives:

(i) Electrogram signature analysis. To use machine learning techniques to identify electrogram properties associated with specific conduction patterns.

(ii) Intracardiac EGM summation. To integrate all acquired points into a global function that allows as precise a determination as possible of the period of isthmus conduction in re-entrant arrhythmias.

(iii) Conduction velocity estimation. To algorithmically determine conduction velocity using proprietary techniques to wholly or partially reduce reliance on LAT annotation.This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia
2. Ability to provide informed consent

Exclusion Criteria:

* Patients who cannot provide informed consent will be excluded. Otherwise, there are no specific exclusion criteria.
Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)

At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks, consisting of two consecutive treatment periods of two weeks evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days follow-up period.

During the course of the study, subjects will be examined for any side effects that may occur (safety and tolerability).

Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837 present in the blood (pharmacokinetics) will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis
* Subjects with gating S1251N CFTR mutation on at least one allele in the CFTR gene
* Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen with ivacaftor, for at least 2 weeks prior to screening
* Weight ≥ 40.0 kg
* Subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor)
* Pre- or post-bronchodilator FEV1 ≥ 40% of predicted normal
* Subject will have to use highly effective contraceptive methods

Exclusion Criteria:

* On an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study
* Concomitant use of antifungal drugs within 4 weeks of baseline
* A history of a clinically meaningful unstable or uncontrolled chronic disease
* Liver cirrhosis and portal hypertension
* Any significant change in the medical regimen for pulmonary health within 4 weeks of baseline
* Unstable pulmonary status or respiratory tract infection or changes in therapy for pulmonary disease within 4 weeks of baseline
* Abnormal liver function
* Clinically significant abnormalities on ECG
* History of malignancy, solid organ/haematological transplantation
* Abnormal renal function
* Participation in another experimental therapy study within 30 days or 5 times half-life
Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers

Chronic cigarette smoking habits often begin in adolescence or early adulthood. 98% of cigarette smokers try their first cigarette before the age of 26. Thus, young adult smokers represent an important target for early smoking cessation intervention. This study tests two interventions designed to increase motivation to quit and decrease smoking behavior. These interventions include: an expectancy challenge approach, which aims to increase negative beliefs about the consequences of smoking; and a behavioral economics approach, which encourages participants to substitute non-smoking behaviors that may still provide reinforcement similar to reinforcement derived from smoking a cigarette.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* English fluency
* Living in the United States
* Smoked at least 1 cigarette per week during the past month
* Willing to be contacted for 1-month follow up assessment

Exclusion Criteria:

* N/A
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.0 kg/m\^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty
Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants

This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.


Eligibility Criteria:
Inclusion Criteria:

- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.

Exclusion Criteria:

* Patients who objected to participating in the study and the processing of their data
* Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up
* Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females

This is a pharmacokinetics and safety study over 3 weekly applications.

Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).

Eligibility Criteria:
Inclusion Criteria:

* Healthy women, ages 18-45 years
* Body mass index 18 - 32, and weight ≥ 110 lbs.
* Willing to use a non-hormonal method of contraception if of childbearing potential, Or have already undergone previous bilateral tubal ligation or hysterectomy
* Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
* Willing to give informed consent to participate in study
* Hemoglobin within normal range.

Exclusion Criteria:

* Known or suspected pregnancy
* A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
* Smoking
* Hypertension (blood pressure \>140 mm Hg systolic and/or \>90 mm Hg diastolic)
* Diabetes Mellitus
* History of headaches with focal neurological symptoms
* Current or history of clinically significant depression in the last year
* Acute or chronic hepatocellular disease with abnormal liver function
* History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
* Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
* Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
* Agree to use effective contraceptive methods as defined by protocol;
* Negative hepatitis panel and HIV screen;
* Sufficient bowel movements (minimum of 1 per day).

Exclusion Criteria:

* History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
* History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
* History of alcoholism or drug addiction within 1 year prior to drug administration;
* Tobacco or nicotine use within 6 months prior to study start;
* Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
* Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
* Inability or unwillingness to swallow capsules;
* Participation in a drug study in which a drug was administered within 30 days prior to study start;
* Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
* Exposure to significant radiation within 12 months prior to study start.
Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates

This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy because they are hiding behind folds and bends in the colon. This research study is being done to determine if performing colonoscopy with a cap on the tip of the colonoscope will reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed against a fold or ridge in order to flatten it, so that the lining on the other side can be more easily seen. This may reduce the miss rate for colon polyps.

Patient will undergo tandem colonoscopy on the same day using propofol sedation. Patients will undergo one colonoscopy without the cap and a second colonoscopy with the cap on. We will endeavor to keep the total examination time equal between the groups and approximately six minutes. The order in which patients receive the two colonoscopies (i.e. cap or without cap first) will be randomized. Any polyps detected during the first colonoscopy will be removed during that procedure. During the withdrawal phase, the time for examination will be measured with a stopwatch, and the stopwatch will be stopped at any time a polyp is located and restarted when the polyp has been removed and retrieved. The stopwatch will also be stopped for suctioning fluid or washing debris from the colon surface. Any polyp detected and removed during the first colonoscopy will be counted as the detection for that procedure. During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older, undergoing scheduled colonoscopy and able to give informed consent.

Exclusion Criteria:

* Previous surgical resection of the colon or rectum
* American Society of Anesthesiology class III or higher
* Inflammatory bowel disease
* Current use of anticoagulants.
Senior Falls Prevention Study

The purpose of this study is to evaluate the effectiveness of a best practice model for senior falls prevention when implemented in a community setting.

This study will measure differences in the incidence of falls and fall risk factors among subjects assigned to an intervention group and a control group. Subjects in the intervention group will receive a multi-faceted intervention based on best practices. Subjects in the control group will receive written fall prevention education materials. Fall monitoring will be conducted for subjects in both groups.

Specific components of the intervention will include:

* an individual fall risk assessment;
* exercise with balance and strength training;
* education on how to reduce falls and fall risk factors; and
* recommendations for medical care management of identified fall risk factors.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older;
* Live in the community in a house, apartment, or retirement center;
* Able to speak and understand English;
* Able to walk without the physical assistance of another person (using an assistive device, such as a cane or walker, is ok);
* Able to participate in a falls prevention program for 12 months;
* Able to participate in exercise classes that meet 3 times per week for a minimum of 6 months.
* Able to provide their own transportation and be a year-round resident;
* Have a health care provider that they had seen within the past three years;
* Able to see and hear another person from a distance of 10 to 12 feet.
* Able to complete a 10-foot Timed Up and Go Test in \< 30 seconds.
* Able to complete the Pfeiffer Short Portable Mental Status Questionnaire with fewer than 5 errors.

Exclusion Criteria:

* Participated in regular, moderate exercise during the past 3 months (Regular exercise means physical activity that is done 30 minutes or longer, 3 or more times a week. Moderate exercise includes any physical activity that makes the heart beat faster or makes a person breathe harder or sweat, such as brisk walking, active gardening, or climbing stairs.)
* Has Parkinson disease or multiple sclerosis;
* Is under doctor's orders to restrict activity level.